CN104771366A - Preparation process of ceftriaxone sodium for injection - Google Patents
Preparation process of ceftriaxone sodium for injection Download PDFInfo
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- CN104771366A CN104771366A CN201510200596.4A CN201510200596A CN104771366A CN 104771366 A CN104771366 A CN 104771366A CN 201510200596 A CN201510200596 A CN 201510200596A CN 104771366 A CN104771366 A CN 104771366A
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Abstract
The invention relates to a preparation process of ceftriaxone sodium for injection. The preparation process comprises the following steps: synthesizing a ceftriaxone sodium wet product; and drying the synthesized ceftriaxone sodium wet product, and crushing into powder, wherein the preparation process of the ceftriaxone sodium powder comprises the steps of firstly, cleaning a reagent bottle for containing the ceftriaxone sodium powder according to a sequence of performing ultrasonic washing, soaking in hot water of 80-100 DEG C for 30-60 minutes, then flushing with warm water of 25 DEG C and performing air drying, oven drying and sterilization, then quantitatively filling the ceftriaxone sodium powder into the cleaned reagent bottle according to a specification, filling nitrogen, covering the reagent bottle by using a pretreated rubber plug, performing cover tying treatment by using an aluminum cover to ensure that the product is sealed, and then sequentially performing inner label pasting, packaging and lamp inspection on the reagent bottle subjected to cover tying. The preparation process provided by the invention overcomes the problem that the existing preparation process of the ceftriaxone sodium for injection easily introduces impurities into the ceftriaxone sodium for injection.
Description
Technical field
The present invention relates to medical drugs preparation technology field, particularly, relate to a kind of preparation technology of ceftriaxone for inj.
Background technology
Ceftriaxone sodium, chemistry (6R, 7R)-7-by name [amino-4 thiazolyl-2-methoxyimino acetylaminos of (Z)-2-]-8-oxygen-5-sulfur-1-azepine [4,2,0]-oct-2-ene-2-formic acid disodium salt.
Ceftriaxone sodium is the long acting antibiotic medicine in Third generation Cephalosporins, it has bactericidal action to many gram positive bacterias, negative bacterium and anaerobe, and highly stable to bacteriogenic most of beta-lactamase, thus enhance its antibacterial action.Be widely used in the respiratory tract infection to this product sensitivity, urinary system infection clinically, comprise nephropyelitis and drench inflammation, meningitis, burn infection, postoperative infection, osteoarthrosis, soft tissue, skin and wound infection, abdominal infection etc. and average of operation periods infection mitigation, at present using the First Line medicine as treatment gonorrhea, it is also one of cephalosporins preparation variety of 22 kinds of clinical practices of state approval.
The effect and the safety that how to improve injecting drug use always are that pharmaceutical producing enterprise wishes the problem solved, the effect of injecting drug use solves from two aspects with safety is main, one is effect and the safety that Formulation guarantees medication, and two is effect and the safety that the process for producing of medicine guarantees medicine.Ceftriaxone for inj is a most existing injection agent, and its prescription is single, guarantees that the effect of its medicine and safe main path are exactly by controlling its preparation technology.
The preparation technology of existing ceftriaxone for inj easily causes introducing impurity in ceftriaxone for inj, and then affects the medicinal effects of ceftriaxone for inj.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of preparation technology of ceftriaxone for inj, easily causes with the preparation technology overcoming existing ceftriaxone for inj the problem introducing impurity in ceftriaxone for inj.
The present invention's adopted technical scheme that solves the problem is: the preparation technology of ceftriaxone for inj, comprises the following steps:
(1), the synthesis of ceftriaxone sodium: 7-amino-cephalosporanic acid, Thiotriazinone react in DMC dimethyl carbonate, generate 7-ACT, then 7-ACT, 2-(2-Amino-4-thiazolyl)-2-methoxyiminoacetic,thiobenzothiazole ester are synthesized ceftriaxone sodium wet product in the binary system of second alcohol and water;
(2), the ceftriaxone sodium wet product of synthesis is dried and pulverize be prepared into Powdered;
(3), the preparation technology of ceftriaxone sodium: first cleaning is used for the reagent bottle of splendid attire ceftriaxone sodium powder, the cleaning process of reagent bottle be followed successively by supersound washing, 80 DEG C ~ 100 DEG C
Hot-water soak 30min-60min, and then with the warm water washing of 25 DEG C, air oven dry, oven for drying, sterilizing, then ceftriaxone sodium powder is quantitatively loaded the above-mentioned reagent bottle cleaned by specification and be filled with nitrogen, then pretreated plug is covered, carry out Zha Gai process with aluminium lid again, product is sealed, interior label, packaging, lamp inspection are pasted successively to the reagent bottle after Zha Gai, then label outer on packing box, then test, pack.Existing ceftriaxone sodium is preparing in process, due to not thorough to cleaning of reagent bottle, easily cause the injectable powder remaining other type at reagent bottle inwall, and then impurity is introduced in ceftriaxone sodium, and then have influence on the medicinal effects of ceftriaxone sodium, the cleaning process of the present invention to reagent bottle is followed successively by supersound washing, the hot-water soak 30min-60min of 80 DEG C ~ 100 DEG C, and then with the warm water washing of 25 DEG C, air is dried, oven for drying, sterilizing, avoid the injectable powder that reagent bottle inwall remains other type, and then avoid ceftriaxone sodium in preparation process because introducing the problem of the ceftriaxone sodium drug effect reduction that impurity causes.
Further, the cleaning process of reagent bottle is followed successively by supersound washing, the hot-water soak 60min of 80 DEG C, and then with the warm water washing of 25 DEG C, air oven dry, oven for drying, sterilizing.Experiment proves, injectable powder can dissolve thoroughly at the hot-water soak 60min of 80 DEG C, further improves the cleaning quality of reagent bottle.
Further, sterilizing adopts dry heat sterilization.The sterilization effect of dry heat sterilization is good and can not cause the humidity in reagent bottle.
Further, the plug of reagent bottle Zha Gai adopts rubber plug cleaning machine cleaning and sterilization treatment.Plug is avoided to have influence on the use of reagent bottle.
Further, aluminium lid need pass through and process, and pretreated concrete steps are: poured into by aluminium lid in clean porose stainless steel framework, add in electrically heated drying cabinet, be incubated powered-down after a hour.
To sum up, the invention has the beneficial effects as follows:
1, the cleaning process of the present invention to reagent bottle be followed successively by supersound washing, 80 DEG C ~ 100 DEG C
Hot-water soak 30min-60min, and then with the warm water washing of 25 DEG C, air oven dry, oven for drying, sterilizing, avoid the injectable powder that reagent bottle inwall remains other type, and then avoid ceftriaxone sodium in preparation process because introducing the problem of the ceftriaxone sodium drug effect reduction that impurity causes.
2, the present invention strictly carries out handle control to each operation in the preparation technology of ceftriaxone sodium, from wash bottle, subpackage, Zha Gai to outer package, all sterilization treatment is carried out to working environment, the problem that its result of use avoiding the performance impairment of the ceftriaxone sodium caused in preparation process to cause reduces from use equipment.
3, the present invention is by all carrying out sterilization treatment to the plug of reagent bottle, Zha Gai and aluminium lid, avoids the problem of the performance impairment of the ceftriaxone sodium caused because of reagent bottle.
Detailed description of the invention
Below in conjunction with embodiment, to the detailed description further of invention do, but embodiments of the present invention are not limited thereto.
Embodiment:
The preparation technology of ceftriaxone for inj, comprises the following steps:
(1), the synthesis of ceftriaxone sodium: 7-amino-cephalosporanic acid, Thiotriazinone react in DMC dimethyl carbonate, generate 7-ACT, then 7-ACT, 2-(2-Amino-4-thiazolyl)-2-methoxyiminoacetic,thiobenzothiazole ester are synthesized ceftriaxone sodium wet product in the binary system of second alcohol and water;
(2), the ceftriaxone sodium wet product of synthesis is dried and pulverize be prepared into Powdered;
(3), the preparation technology of ceftriaxone sodium: first cleaning is used for the reagent bottle of splendid attire ceftriaxone sodium powder, the cleaning process of reagent bottle is followed successively by supersound washing, the hot-water soak 60min of 80 DEG C, and then with the warm water washing of 25 DEG C, air is dried, oven for drying, dry heat sterilization, then ceftriaxone sodium powder is quantitatively loaded the above-mentioned reagent bottle cleaned by specification and be filled with nitrogen, then pretreated plug is covered, Zha Gai process is carried out again with aluminium lid, product is sealed, successively interior label is pasted to the reagent bottle after Zha Gai, packaging, lamp inspection, then label outer on packing box, test again, packing, the plug of described reagent bottle Zha Gai adopts rubber plug cleaning machine cleaning and sterilization treatment, described aluminium lid need pass through and process, pretreated concrete steps are: poured into by aluminium lid in clean porose stainless steel framework, add in electrically heated drying cabinet, be incubated powered-down after a hour.
As mentioned above, the present invention can be realized preferably.
Claims (5)
1. the preparation technology of ceftriaxone for inj, is characterized in that, comprises the following steps:
(1), the synthesis of ceftriaxone sodium: 7-amino-cephalosporanic acid, Thiotriazinone react in DMC dimethyl carbonate, generate 7-ACT, then 7-ACT, 2-(2-Amino-4-thiazolyl)-2-methoxyiminoacetic,thiobenzothiazole ester are synthesized ceftriaxone sodium wet product in the binary system of second alcohol and water;
(2), the ceftriaxone sodium wet product of synthesis is dried and pulverize be prepared into Powdered;
(3), the preparation technology of ceftriaxone sodium: first cleaning is used for the reagent bottle of splendid attire ceftriaxone sodium powder, the cleaning process of reagent bottle be followed successively by supersound washing, 80 DEG C ~ 100 DEG C
Hot-water soak 30min-60min, and then with the warm water washing of 25 DEG C, air oven dry, oven for drying, sterilizing, then ceftriaxone sodium powder is quantitatively loaded the above-mentioned reagent bottle cleaned by specification and be filled with nitrogen, then pretreated plug is covered, carry out Zha Gai process with aluminium lid again, product is sealed, interior label, packaging, lamp inspection are pasted successively to the reagent bottle after Zha Gai, then label outer on packing box, then test, pack.
2. the preparation technology of ceftriaxone for inj according to claim 1, it is characterized in that, the cleaning process of described reagent bottle is followed successively by supersound washing, the hot-water soak 60min of 80 DEG C, and then with the warm water washing of 25 DEG C, air oven dry, oven for drying, sterilizing.
3. the preparation technology of ceftriaxone for inj according to claim 1 and 2, is characterized in that, described sterilizing adopts dry heat sterilization.
4. the preparation technology of ceftriaxone for inj according to claim 3, is characterized in that, the plug of described reagent bottle Zha Gai adopts rubber plug cleaning machine cleaning and sterilization treatment.
5. the preparation technology of ceftriaxone for inj according to claim 4, it is characterized in that, described aluminium lid need pass through and process, and pretreated concrete steps are: poured into by aluminium lid in clean porose stainless steel framework, add in electrically heated drying cabinet, be incubated powered-down after a hour.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201510200596.4A CN104771366A (en) | 2015-04-27 | 2015-04-27 | Preparation process of ceftriaxone sodium for injection |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510200596.4A CN104771366A (en) | 2015-04-27 | 2015-04-27 | Preparation process of ceftriaxone sodium for injection |
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| CN104771366A true CN104771366A (en) | 2015-07-15 |
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| CN201510200596.4A Pending CN104771366A (en) | 2015-04-27 | 2015-04-27 | Preparation process of ceftriaxone sodium for injection |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107412167A (en) * | 2017-04-26 | 2017-12-01 | 四川制药制剂有限公司 | The production method of ceftriaxone sodium for injection |
| CN110396101A (en) * | 2018-12-03 | 2019-11-01 | 广东金城金素制药有限公司 | Qu Suofen Ceftriaxone Sodium pharmaceutical preparation treats the new indication of bacillary intimitis |
| CN111646418A (en) * | 2020-06-08 | 2020-09-11 | 耿超玮 | Production line is loaded to bacterin |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102895182A (en) * | 2012-10-22 | 2013-01-30 | 四川制药制剂有限公司 | Method for preparing cefoxitin sodium for injection |
| CN103539803A (en) * | 2013-07-27 | 2014-01-29 | 珠海保税区丽珠合成制药有限公司 | Method for preparing ceftriaxone sodium |
-
2015
- 2015-04-27 CN CN201510200596.4A patent/CN104771366A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102895182A (en) * | 2012-10-22 | 2013-01-30 | 四川制药制剂有限公司 | Method for preparing cefoxitin sodium for injection |
| CN103539803A (en) * | 2013-07-27 | 2014-01-29 | 珠海保税区丽珠合成制药有限公司 | Method for preparing ceftriaxone sodium |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107412167A (en) * | 2017-04-26 | 2017-12-01 | 四川制药制剂有限公司 | The production method of ceftriaxone sodium for injection |
| CN110396101A (en) * | 2018-12-03 | 2019-11-01 | 广东金城金素制药有限公司 | Qu Suofen Ceftriaxone Sodium pharmaceutical preparation treats the new indication of bacillary intimitis |
| CN111646418A (en) * | 2020-06-08 | 2020-09-11 | 耿超玮 | Production line is loaded to bacterin |
| CN111646418B (en) * | 2020-06-08 | 2022-09-20 | 北京华诺泰生物医药科技有限公司 | Production line is loaded to bacterin |
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Application publication date: 20150715 |