CN104840434A - Product qualified rate improving preparation method for cefuroxime sodium for injection - Google Patents
Product qualified rate improving preparation method for cefuroxime sodium for injection Download PDFInfo
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- CN104840434A CN104840434A CN201510200608.3A CN201510200608A CN104840434A CN 104840434 A CN104840434 A CN 104840434A CN 201510200608 A CN201510200608 A CN 201510200608A CN 104840434 A CN104840434 A CN 104840434A
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Abstract
The invention relates to a product qualified rate improving preparation method for cefuroxime sodium for injection. The method includes the steps of: first synthesis of cefoxitin sodium into a wet product, then powdering of cefoxitin sodium, and then preparation process, which includes: firstly cleaning a reagent bottle for holding cefoxitin sodium, then loading the cefoxitin sodium powder into the cleaned reagent bottle quantitatively according to specifications, filling the cefoxitin sodium powder filled reagent bottle with nitrogen, covering the reagent bottle with a pretreated rubber plug, then carrying out aluminum cover tying treatment to seal the product, subjecting the tied reagent bottle to inner label pasting, packaging and lamp inspection in order, then pasting an outer label on the packaging box, and then conducting inspection and packing. With the method provided by the invention, the product quality reduction problem caused by a lot of unqualified products in existing injection cefoxitin sodium preparation technologies can be overcome.
Description
Technical field
The present invention relates to medical drugs preparation method field, particularly, relate to a kind of preparation method improving the cefuroxime sodium for injection of conforming product rate.
Background technology
Cefuroxime Sodium, chemistry (6R, 7R)-7-[2-furyl (methoxyimino) acetylamino]-3-carbamoyloxymethyl-8-oxo-5-thia-1-azabicyclic [4.2.0] oct-2-ene-2-formic acid sodium salt by name.
Cefuroxime Sodium is second generation cephalosporin class antibiotic, similar to first generation cephalosporin or slightly poor to the antibacterial activity of gram positive coccus, but to the beta lactamase quite stable that staphylococcus and gram negative bacilli produce.Methicillin-resistant Staphylococcus, Enterococcus and Listerella number drug resistance, other this this product of positive cocci is responsive.Can be used for the pneumonia caused by sensitive bacterial and other lower respiratory infection, urinary tract infection, meningitis, septicemia, abdominal cavity infection, pelvic infection, skin soft-tissue infection, reproductive tract infection, bone and the infection of joint etc.This medicine antibacterial is extensively general, and fastbacteria is few, is clinical conventional antibiotic.
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.Cefoxitin sodium for injection 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 injection cefoxitin sodium easily causes cefoxitin sodium for injection finished product to produce more defective work, reduces the quality of product.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of preparation method improving the cefuroxime sodium for injection of conforming product rate, the problem of the quality reduction of the product easily caused because substandard product is more with the preparation technology overcoming existing injection cefoxitin sodium.
The present invention's adopted technical scheme that solves the problem is: the preparation method improving the cefuroxime sodium for injection of conforming product rate, comprises the following steps:
(1), the synthesis of Cefuroxime Sodium: add in a reservoir dehydrated alcohol or methanol,
Sodium lactate aqueous solution and Sodium isooctanoate., be stirred to Sodium isooctanoate. all to dissolve, obtain sodium liquid, wherein, in described sodium liquid, it is 2:43 ~ 43:2 that Sodium isooctanoate. and sodium lactate obtain mol ratio, acetone, water and cefuroxime acid is added in another container, stirring makes cefuroxime acid dissolve completely, adds active carbon, stirs decolouring, filter, obtain cefuroxime acid filtrate, cefuroxime acid filtrate joined in sodium liquid, sodium liquid measure is greater than the amount of cefuroxime acid filtrate, stir, produce precipitation, filter, obtain Cefuroxime Sodium wet product;
(2), by the Cefuroxime Sodium wet product of synthesis respectively with after the mixed liquor washing of methanol/acetone, then with acetone soln washing, dry and be prepared into Powdered;
(3), the preparation technology of Cefuroxime Sodium: first cleaning is used for the reagent bottle of splendid attire Cefuroxime Sodium powder, then Cefuroxime Sodium powder is quantitatively loaded the above-mentioned reagent bottle cleaned by specification, again the reagent bottle that Cefuroxime Sodium powder is housed is 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, in above-mentioned preparation process, adopt control system to control, described control system comprises Surveillance center, Surveillance center is connected with controller, controller is connected with setting weight sensor on the belt, conveyer belt start stop switch, controller is connected with the weighing machine being arranged on conveyer belt outfan, fully loaded channel switching, unloaded channel switching, controller is connected with the automatic camera camera be arranged on fully loaded passage, unlabelled channel switching, certified products channel switching, described Surveillance center is connected with network service by network interface, and described controller is connected with enumerator, and Surveillance center is connected with data center.The defective speed due to assembly line work of the cefoxitin sodium for injection finished product that the preparation technology of existing injection cefoxitin sodium easily causes, manual operation does not catch up with the speed of conveyer belt sometimes, reagent bottle usually can be caused to occur unloaded, the appearance of the substandard products such as reagent bottle unlabelled, Surveillance center of the present invention specifically refers to Control Room, for the whole production procedure of same monitoring management, controller specifically refers to PLC, zero load refers in reagent bottle have splendid attire powder reagent, be fully loaded with the powder reagent referring in reagent bottle and be loaded with specification and arrange, weight sensor can be real-time the weight sensing the product on conveyer belt, when product have little time flow into next process cause blocking up on a moving belt time, driving-belt is overweight, weight sensor by the weight transmitting that senses to controller, judged whether overweight by controller, and judge whether that sending instruction stops conveyer belt, when product flow into the outfan of driving-belt, weighed not obtaining reagent bottle by weighing machine, the numerical value of weighing is passed to controller, according to numerical value, controller judges that whether this reagent bottle is unloaded, if unloaded controller sends instruction and opens unloaded channel switching, make product introduction arrive unloaded passage, otherwise open fully loaded channel switching, avoid unloaded defective work to flow into next process, the reagent bottle flowing into fully loaded passage is taken pictures through automatic licence plate camera, license plate information is passed to controller, judge whether reagent bottle labels by controller, if unlabelled, controller sends instruction and opens unlabelled channel switching, make product introduction to unlabelled passage, otherwise opening certified products channel switching makes product introduction to certified products passage, the present invention, by arranging weighing machine, fully loaded channel switching, unloaded channel switching at the outfan of conveyer belt, avoids the problem of reagent bottle zero load, by being provided with automatic camera camera, unlabelled channel switching, certified products channel switching on fully loaded passage, avoid the problem of reagent bottle unlabelled, so, the problem of the quality reduction of the product that the preparation technology that instant invention overcomes existing injection cefoxitin sodium easily causes because substandard product is more.
Further, controller is connected to temperature sensor, and the temperature signal sensed is passed to controller by temperature sensor, and controller analysis temperature signal judges whether the heater that unlatching is connected with controller or heat abstractor.Report and submit to controller by temperature sensor acquisition environment temperature, controller carries out the calculating of temperature data and compares, when temperature is lower than setting value time, start electro-heat equipment, and can the power of regulation heating device, thus keep whole controller not affected by too low temperature, and when ambient temperature is higher than certain setting value, start heat abstractor, and environmentally the height of temperature carrys out the power of adjusting heat dissipation device, electronic component is made to be unlikely to be burned, thus make each electronic devices and components keep more rational operating temperature, add the service life of equipment.
Further, controller is connected with photographic head, the picture via controller of photographic head shooting passes to the computer be connected with Surveillance center.So, the production procedure observing product that just can be real-time.
Further, Sodium isooctanoate. and sodium lactate obtain mol ratio is 2:7 ~ 7:2.Sodium isooctanoate. and sodium lactate are obtained mol ratio to be set to, into 2:7 ~ 7:2, solution rapid solution can be made.
Further, the solution temperature of cefuroxime acid is 30 DEG C ~ 35 DEG C.Cefuroxime acid is 30 DEG C ~ 35 DEG C in temperature and has good dissolution velocity.
To sum up, the invention has the beneficial effects as follows:
1, the present invention is by arranging weighing machine, fully loaded channel switching, unloaded channel switching at the outfan of conveyer belt, avoids the problem of reagent bottle zero load; By being provided with automatic camera camera, unlabelled channel switching, certified products channel switching on fully loaded passage, avoid the problem of reagent bottle unlabelled.
2, the present invention is set to 2:7 ~ 7:2 by Sodium isooctanoate. and sodium lactate are obtained mol ratio; The solution temperature of cefuroxime acid is set to 30 DEG C ~ 35 DEG C, accelerates the dissolution velocity of cefuroxime acid, improves the allocative efficiency of solution.
Accompanying drawing explanation
Fig. 1 is theory diagram of the present invention.
Detailed description of the invention
Below in conjunction with embodiment and accompanying drawing, to the detailed description further of invention do, but embodiments of the present invention are not limited thereto.
Embodiment:
As shown in Figure 1, improve the preparation method of the cefuroxime sodium for injection of conforming product rate, comprise the following steps:
(1), the synthesis of Cefuroxime Sodium: add in a reservoir dehydrated alcohol or methanol,
Sodium lactate aqueous solution and Sodium isooctanoate., be stirred to Sodium isooctanoate. all to dissolve, solution temperature is set to 30 DEG C, obtains sodium liquid, wherein, in described sodium liquid, it is 2:7 that Sodium isooctanoate. and sodium lactate obtain mol ratio, in another container, add acetone, water and cefuroxime acid, stirs and cefuroxime acid is dissolved completely, add active carbon, stir decolouring, filter, obtain cefuroxime acid filtrate, cefuroxime acid filtrate is joined in sodium liquid, sodium liquid measure is greater than the amount of cefuroxime acid filtrate, stirs, and produces precipitation, filter, obtain Cefuroxime Sodium wet product;
(2), by the Cefuroxime Sodium wet product of synthesis respectively with after the mixed liquor washing of methanol/acetone, then with acetone soln washing, dry and be prepared into Powdered;
(3), the preparation technology of Cefuroxime Sodium: first cleaning is used for the reagent bottle of splendid attire Cefuroxime Sodium powder, then Cefuroxime Sodium powder is quantitatively loaded the above-mentioned reagent bottle cleaned by specification, again the reagent bottle that Cefuroxime Sodium powder is housed is 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, in above-mentioned preparation process, adopt control system to control, described control system comprises Surveillance center, Surveillance center is connected with controller, controller is connected with setting weight sensor on the belt, conveyer belt start stop switch, controller is connected with the weighing machine being arranged on conveyer belt outfan, fully loaded channel switching, unloaded channel switching, controller is connected with the automatic camera camera be arranged on fully loaded passage, unlabelled channel switching, certified products channel switching, described Surveillance center is connected with network service by network interface, described controller is connected with enumerator, described controller is connected to temperature sensor, the temperature signal sensed is passed to controller by temperature sensor, controller analysis temperature signal judges whether the heater that unlatching is connected with controller or heat abstractor, described controller is connected with photographic head, and the picture via controller of photographic head shooting passes to the computer be connected with Surveillance center, and Surveillance center is connected with data center.
As mentioned above, the present invention can be realized preferably.
Claims (5)
1. improve the preparation method of the cefuroxime sodium for injection of conforming product rate, it is characterized in that, comprise the following steps:
(1), the synthesis of Cefuroxime Sodium: add in a reservoir dehydrated alcohol or methanol,
Sodium lactate aqueous solution and Sodium isooctanoate., be stirred to Sodium isooctanoate. all to dissolve, obtain sodium liquid, wherein, in described sodium liquid, it is 2:43 ~ 43:2 that Sodium isooctanoate. and sodium lactate obtain mol ratio, acetone, water and cefuroxime acid is added in another container, stirring makes cefuroxime acid dissolve completely, adds active carbon, stirs decolouring, filter, obtain cefuroxime acid filtrate, cefuroxime acid filtrate joined in sodium liquid, sodium liquid measure is greater than the amount of cefuroxime acid filtrate, stir, produce precipitation, filter, obtain Cefuroxime Sodium wet product;
(2), by the Cefuroxime Sodium wet product of synthesis respectively with after the mixed liquor washing of methanol/acetone, then with acetone soln washing, dry and be prepared into Powdered;
(3), the preparation technology of Cefuroxime Sodium: first cleaning is used for the reagent bottle of splendid attire Cefuroxime Sodium powder, then Cefuroxime Sodium powder is quantitatively loaded the above-mentioned reagent bottle cleaned by specification, again the reagent bottle that Cefuroxime Sodium powder is housed is 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, in above-mentioned preparation process, adopt control system to control, described control system comprises Surveillance center, Surveillance center is connected with controller, controller is connected with setting weight sensor on the belt, conveyer belt start stop switch, controller is connected with the weighing machine being arranged on conveyer belt outfan, fully loaded channel switching, unloaded channel switching, controller is connected with the automatic camera camera be arranged on fully loaded passage, unlabelled channel switching, certified products channel switching, described Surveillance center is connected with network service by network interface, and described controller is connected with enumerator, and Surveillance center is connected with data center.
2. the preparation method of the cefuroxime sodium for injection of raising conforming product rate according to claim 1, it is characterized in that, described controller is connected to temperature sensor, the temperature signal sensed is passed to controller by temperature sensor, and controller analysis temperature signal judges whether the heater that unlatching is connected with controller or heat abstractor.
3. the preparation method of the cefuroxime sodium for injection of raising conforming product rate according to claim 1 and 2, is characterized in that, described controller is connected with photographic head, and the picture via controller of photographic head shooting passes to the computer be connected with Surveillance center.
4. the preparation method of the cefuroxime sodium for injection of raising conforming product rate according to claim 1, is characterized in that, it is 2:7 ~ 7:2 that described Sodium isooctanoate. and sodium lactate obtain mol ratio.
5. the preparation method of the cefuroxime sodium for injection of raising conforming product rate according to claim 4, is characterized in that, the solution temperature of described cefuroxime acid is 30 DEG C ~ 35 DEG C.
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040141925A1 (en) * | 1998-11-12 | 2004-07-22 | Elan Pharma International Ltd. | Novel triamcinolone compositions |
| CN101955492A (en) * | 2009-07-15 | 2011-01-26 | 上海新先锋药业有限公司 | Preparation method of cefuroxime sodium |
| 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 |
| CN104035417A (en) * | 2014-06-14 | 2014-09-10 | 国网四川省电力公司双流县供电分公司 | Production management system |
| CN204086931U (en) * | 2014-02-28 | 2015-01-07 | 楚天科技股份有限公司 | For the centralized monitoring system of aseptic medicine lyophilized formulations production line |
-
2015
- 2015-04-27 CN CN201510200608.3A patent/CN104840434A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040141925A1 (en) * | 1998-11-12 | 2004-07-22 | Elan Pharma International Ltd. | Novel triamcinolone compositions |
| CN101955492A (en) * | 2009-07-15 | 2011-01-26 | 上海新先锋药业有限公司 | Preparation method of cefuroxime sodium |
| 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 |
| CN204086931U (en) * | 2014-02-28 | 2015-01-07 | 楚天科技股份有限公司 | For the centralized monitoring system of aseptic medicine lyophilized formulations production line |
| CN104035417A (en) * | 2014-06-14 | 2014-09-10 | 国网四川省电力公司双流县供电分公司 | Production management system |
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Application publication date: 20150819 |
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