CN104761570A - Preparation technology for ceftazidime for injection - Google Patents
Preparation technology for ceftazidime for injection Download PDFInfo
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- CN104761570A CN104761570A CN201510200615.3A CN201510200615A CN104761570A CN 104761570 A CN104761570 A CN 104761570A CN 201510200615 A CN201510200615 A CN 201510200615A CN 104761570 A CN104761570 A CN 104761570A
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- China
- Prior art keywords
- ceftazidime
- preparation technology
- reagent bottle
- ceftazime
- powder
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D501/00—Heterocyclic compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins; Such ring systems being further condensed, e.g. 2,3-condensed with an oxygen-, nitrogen- or sulfur-containing hetero ring
- C07D501/02—Preparation
- C07D501/04—Preparation from compounds already containing the ring or condensed ring systems, e.g. by dehydrogenation of the ring, by introduction, elimination or modification of substituents
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D501/00—Heterocyclic compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins; Such ring systems being further condensed, e.g. 2,3-condensed with an oxygen-, nitrogen- or sulfur-containing hetero ring
- C07D501/02—Preparation
- C07D501/04—Preparation from compounds already containing the ring or condensed ring systems, e.g. by dehydrogenation of the ring, by introduction, elimination or modification of substituents
- C07D501/06—Acylation of 7-aminocephalosporanic acid
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D501/00—Heterocyclic compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins; Such ring systems being further condensed, e.g. 2,3-condensed with an oxygen-, nitrogen- or sulfur-containing hetero ring
- C07D501/14—Compounds having a nitrogen atom directly attached in position 7
- C07D501/16—Compounds having a nitrogen atom directly attached in position 7 with a double bond between positions 2 and 3
- C07D501/20—7-Acylaminocephalosporanic or substituted 7-acylaminocephalosporanic acids in which the acyl radicals are derived from carboxylic acids
- C07D501/24—7-Acylaminocephalosporanic or substituted 7-acylaminocephalosporanic acids in which the acyl radicals are derived from carboxylic acids with hydrocarbon radicals, substituted by hetero atoms or hetero rings, attached in position 3
- C07D501/38—Methylene radicals, substituted by nitrogen atoms; Lactams thereof with the 2-carboxyl group; Methylene radicals substituted by nitrogen-containing hetero rings attached by the ring nitrogen atom; Quaternary compounds thereof
- C07D501/46—Methylene radicals, substituted by nitrogen atoms; Lactams thereof with the 2-carboxyl group; Methylene radicals substituted by nitrogen-containing hetero rings attached by the ring nitrogen atom; Quaternary compounds thereof with the 7-amino radical acylated by carboxylic acids containing hetero rings
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- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to preparation technology for ceftazidime for injection. The preparation technology comprises the following steps that a ceftazidime wet product is synthesized; the synthesized ceftazidime wet product is dried and crushed to be prepared to be in a powder shape. The preparation technology of ceftazidime powder comprises the steps that a reagent bottle used for containing the ceftazidime powder is washed, and the washing process of the reagent bottle sequentially comprises ultrasonic washing, 80-100 DEG C hot water soaking for 30 min-60 min, 25 DEG C warm water washing, air drying, drying oven drying and sterilizing; the ceftazidime powder is contained into the washed reagent bottle, nitrogen is filled in the reagent bottle, the reagent bottle is covered by a preprocessed rubber plug, and cover fastening processing is performed by using an aluminum cover; interior label pasting, packaging and light inspecting are sequentially performed on the fastened reagent bottle. According to the preparation technology, the problems caused by the existing preparation technology of the ceftazidime for the injection that the product yield is low, the product quality is not stable and the medicine effects of the ceftazidime for injection are reduced caused by the fact that impurities are prone to being introduced into the ceftazidime are solved.
Description
Technical field
The present invention relates to medical drugs preparation technology field, particularly, relate to a kind of preparation technology of ceftazidime for inj.
Background technology
Ceftazime belongs to third generation cephalosporin analog antibiotic, is found, nineteen eighty-three in 1978, and first Ge Lansu company of Britain is developed listing.1992, ceftazime, in China's Initial Public Offering, was formally listed in China's essential drug list in 1993.Through the clinical application checking of more than 10 years, ceftazime has the feature such as has a broad antifungal spectrum, resistance to enzyme, it is comparatively strong to the anti-microbial activity of Pseudomonas aeruginosa, be widely used in treatment various in, severe infection, be the choice drug that gram negative bacterium harm patient is infected in treatment.
The chemical name of ceftazime is: (6R, 7R)-7-[[(2-amino-4-thiazolyl)-[(1-carboxyl-1-methyl ethoxy) imino-] ethanoyl]-2-carboxyl-8-oxo-5-oxo-thia-1-azabicyclo [4.2.0] oct-2-ene-3-methyl arsenic pyridine drone inner salt pentahapto hydrate.
The effect and the security that how to improve injecting drug use always are that drug manufacturing 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.The product yield of the synthesis of existing ceftazime is lower, and the product of synthesis is second-rate; Easily impurity is introduced in the preparation process of existing ceftazime.
The preparation technology of existing ceftazidime for inj causes the lower and unstable product quality of the yield of product, easily in ceftazime, introduces impurity and then reduce the drug effect of ceftazidime for inj preparation.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of preparation technology of ceftazidime for inj, causes the lower and unstable product quality of the yield of product with the preparation technology overcoming existing ceftazidime for inj, easily in ceftazime, introduces impurity and then reduce the problem of drug effect of ceftazidime for inj preparation.
The present invention's adopted technical scheme that solves the problem is: the preparation technology of ceftazidime for inj, comprises the following steps:
(1), the synthesis of ceftazime: with intermediate 7-ACA for starting raw material, with hexamethyldisilazane silylation reagent the most, obtain ceftazidime pentahydrate through 3 substitution reactions, 7 acylation reactions, then obtain ceftazime wet product through dehydration reaction;
(2), the ceftazime wet product of synthesis is dried and pulverize be prepared into Powdered;
(3), the preparation technology of ceftazime: first cleaning is used for the reagent bottle of splendid attire ceftazime 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 ceftazime 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.The product yield of the synthesis of existing ceftazime is lower, and the product of synthesis is second-rate, the preparation process of existing ceftazime cannot carry out real-time monitoring management, the present invention adopts hexamethyldisilazane as silylating agent, and reaction conditions is gentle, no coupling product during reaction, not only increase the yield of product, and improve the stability of quality product, 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 powder injection that reagent bottle inwall remains other type, and then avoid ceftazime in preparation process because introducing the problem of the ceftazime drug effect reduction that impurity causes, so, the preparation technology that instant invention overcomes existing ceftazidime for inj causes the lower and unstable product quality of the yield of product, in ceftazime, easily introduce the problem of the drug effect of impurity and then reduction ceftazidime for inj preparation.
Further, nitrogen is passed in the bottom of liquid in the building-up process of ceftazime.Nitrogen is passed into subsurface protected mode, timely and effectively except the ammonia produced in dereaction, the quality of product can be guaranteed further.
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, powder injection 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 sterilization.The sterilising effect of dry 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 sterilising 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 present invention adopts hexamethyldisilazane as silylating agent, and reaction conditions is gentle, and no coupling product during reaction, not only increases the yield of product, and improves the stability of quality product.
2, 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 oven dry, oven for drying, sterilizing, avoid the powder injection that reagent bottle inwall remains other type, and then avoid ceftazime in preparation process because introducing the problem of the ceftazime drug effect reduction that impurity causes.
Embodiment
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 ceftazidime for inj, comprises the following steps:
(1), the synthesis of ceftazime: with intermediate 7-ACA for starting raw material, with hexamethyldisilazane silylation reagent the most, ceftazidime pentahydrate is obtained through 3 substitution reactions, 7 acylation reactions, obtain ceftazime wet product through dehydration reaction again, in building-up process, pass into nitrogen in liquid bottom;
(2), the ceftazime wet product of synthesis is dried and pulverize be prepared into Powdered;
(3), the preparation technology of ceftazime: first cleaning is used for the reagent bottle of splendid attire ceftazime 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 sterilization, then ceftazime 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 is examined, then label outer on packing box, test again, packing, the plug of described reagent bottle Zha Gai adopts rubber plug cleaning machine cleaning and sterilising 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 (6)
1. the preparation technology of ceftazidime for inj, is characterized in that, comprises the following steps:
(1), the synthesis of ceftazime: with intermediate 7-ACA for starting raw material, with hexamethyldisilazane silylation reagent the most, obtain ceftazidime pentahydrate through 3 substitution reactions, 7 acylation reactions, then obtain ceftazime wet product through dehydration reaction;
(2), the ceftazime wet product of synthesis is dried and pulverize be prepared into Powdered;
(3), the preparation technology of ceftazime: first cleaning is used for the reagent bottle of splendid attire ceftazime 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 ceftazime 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 ceftazidime for inj according to claim 1, is characterized in that, the bottom at liquid in the building-up process of described ceftazime passes into nitrogen.
3. the preparation technology of ceftazidime 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.
4. the preparation technology of the ceftazidime for inj according to claim 1 or 3, is characterized in that, described sterilizing adopts dry sterilization.
5. the preparation technology of ceftazidime for inj according to claim 4, is characterized in that, the plug of described reagent bottle Zha Gai adopts rubber plug cleaning machine cleaning and sterilising treatment.
6. the preparation technology of ceftazidime for inj according to claim 5, 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 |
|---|---|---|---|
| CN201510200615.3A CN104761570A (en) | 2015-04-27 | 2015-04-27 | Preparation technology for ceftazidime for injection |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510200615.3A CN104761570A (en) | 2015-04-27 | 2015-04-27 | Preparation technology for ceftazidime for injection |
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| CN104761570A true CN104761570A (en) | 2015-07-08 |
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| CN201510200615.3A Pending CN104761570A (en) | 2015-04-27 | 2015-04-27 | Preparation technology for ceftazidime for injection |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102286003A (en) * | 2011-08-05 | 2011-12-21 | 哈药集团制药总厂 | Synthesis method of ceftazidime |
| CN102875576A (en) * | 2012-10-31 | 2013-01-16 | 苏州致君万庆药业有限公司 | Synthesis of antibiotic ceftazidime, ceftazidime for injection and preparation method of ceftazidime |
-
2015
- 2015-04-27 CN CN201510200615.3A patent/CN104761570A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102286003A (en) * | 2011-08-05 | 2011-12-21 | 哈药集团制药总厂 | Synthesis method of ceftazidime |
| CN102875576A (en) * | 2012-10-31 | 2013-01-16 | 苏州致君万庆药业有限公司 | Synthesis of antibiotic ceftazidime, ceftazidime for injection and preparation method of ceftazidime |
Non-Patent Citations (2)
| Title |
|---|
| 刘煜婷: "第三代头孢菌素-头孢他啶的合成工艺研究", 《沈阳药科大学硕士学位论文》 * |
| 郑玉林: "头孢他啶的合成工艺改进", 《中国药物化学杂志》 * |
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Application publication date: 20150708 |
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