CN102579431A - Preparation process of imipenem and cilastatin sodium for injection - Google Patents
Preparation process of imipenem and cilastatin sodium for injection Download PDFInfo
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- CN102579431A CN102579431A CN2011104547790A CN201110454779A CN102579431A CN 102579431 A CN102579431 A CN 102579431A CN 2011104547790 A CN2011104547790 A CN 2011104547790A CN 201110454779 A CN201110454779 A CN 201110454779A CN 102579431 A CN102579431 A CN 102579431A
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- imipenem
- cilastatin sodium
- sodium
- cilastatin
- injection
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Abstract
The invention discloses a preparation process of imipenem and cilastatin sodium for injection. According to a prescription, the imipenem and cilastatin sodium comprises imipenem, cilastatin sodium and sodium bicarbonate, wherein the imipenem is an antibacterial agent; the cilastatin sodium is a dehydrogenization peptidase inhibitor; and the sodium bicarbonate is an auxiliary material and is used as a solubilizing agent (increasing the solubility of the imipenem) and a pH regulator. The preparation process of the imipenem and cilastatin sodium for injection comprises the following steps of: (1) mixing in a sterile mode; (2) cleaning a penicillin bottle, a butyl rubber stopper and an aluminum plastic cover, and sterilizing; and (3) split-charging.
Description
Technical field
The present invention relates to field of medicaments, be specifically related to a kind of preparation technology of imipenem for injection Cilastatin Sodium.
Background technology
Imipenem cilastatin sodium, Imipenem and Cilastatin Sodium is carbapenems (training south class) compound antibiotic, its Main Ingredients and Appearance is imipenum and Cilastatin Sodium.Imipenum is a kind of state-of-the art beta-Lactam antibiotic-imipenem, also is amidino derivatives, and antimicrobial spectrum is extremely wide, and Grain-negative and positive bacteria, aerobe and anaerobe are all had good antibacterial activity.Cilastatin Sodium is a kind of specificity enzyme inhibitor, and it can block the metabolism of imipenum in kidney, thereby improves imipenum original shape drug concentrations in the urinary tract.
Imipenem cilastatin sodium is a unusual broad-spectrum antibiotic, is specially adapted to several diseases substance make peace microbial mixed infection of aerobic/anaerobism and the early treatment before pathogen is not confirmed.These article are applicable to by the caused IAI of sensitive bacterial; Lower respiratory infection; Gynecological infection; Septicemia; Urogenital infections; Bone joint infection; Skin soft-tissue infection; Endocarditis etc.
Injection is to use one of the most extensive most important dosage form, and it has advantage: 1. effect is reliable rapidly, and its medicinal liquid directly injects tissue or blood vessel, and no absorption process or absorption process are very short, thereby haemoconcentration can arrive the peak rapidly and plays a role.Again because of its without digestive tract, not influenced by pH, enzyme, food etc., no first pass effect, medicament contg are difficult for loss, so curative effect is reliable, can be used for rescuing the crisis patient.2. be applicable to unsuitable oral medicine, be prone to by destructive medicine of Digestive system or the significant medicine of first pass effect, and should not absorb after oral or the medicine bigger, all can design and process injection the digestive tract zest.3. be applicable to can not oral drugs patient, the patient that maybe can not swallow like stupor.4. can bring into play the effect of local positioning, like the use of local anaesthetics and the local radiography of contrast agent.That Cilastatin Sodium of imipenem for injection is the kind of going on the market, and 0.5g, 1.0g, many specifications of 2.0g are arranged.At present domestic have 5 tame enterprises to develop this product in succession, the import registration 6 families are arranged.Antibacterial action is strong, the effect of has a broad antifungal spectrum event is used widely clinically because of it has.
Summary of the invention
Key technology of the present invention shows craft screening and optimization; We according to the rule of the aseptic subpackaged powder injection formulation preparation of pharmaceutics, serve as to detect index with content, related substance etc. according to the character of imipenem cilastatin sodium; Preferred this preparation process is finally confirmed technological process.
Comprise imipenum, Cilastatin Sodium and sodium bicarbonate in the imipenem cilastatin sodium prescription of the present invention; Wherein imipenum is an antibacterial; Cilastatin Sodium is the dehydropeptidase inhibitor, and sodium bicarbonate is an adjuvant, as solubilizing agent (increasing the dissolubility of imipenum) and PH regulator.
Further, the mass ratio of imipenum in the prescription and Cilastatin Sodium is 1:1.
Further, the imipenum in the prescription: Cilastatin Sodium: sodium bicarbonate=1:1: (0.01-0.1) (mass ratio).
The preparation technology of imipenem for injection Cilastatin Sodium provided by the invention may further comprise the steps:
(1) aseptic mixing
Cilastatin Sodium, imipenum and sodium bicarbonate are obtained aseptic imipenem cilastatin sodium mixing intermediate in 20 ~ 24 ℃ of local laminar flows mixing, and after check, mix homogeneously is for use;
(2) cleaning of cillin bottle, butyl rubber plug, aluminium-plastic cap and sterilization
After the ultrasound wave wash bottle, reuse purified water, water for injection flushing are subsequently through the sterilization in 5 minutes more than 350 ℃ of tunnel baking oven with cillin bottle;
Through ultrasonic waves for cleaning, 121 ℃ of steam sterilizations of warp are 30 minutes again with butyl rubber plug, and vacuum drying is 90 minutes subsequently, 120 ℃ of xeothermic 2h sterilizations;
Aluminium-plastic cap was through 120 ℃ of sterilizations 1.5 hours;
(3) packing
Aseptic imipenem cilastatin sodium mixing intermediate is obtained semi-finished product in 20 ~ 24 ℃ of local laminar flows, through lamp inspection, labeling, pack finished product to be checked, after the check certified products, the warehouse-in.
The specific embodiment
Below in conjunction with concrete embodiment scheme of the present invention is further described.For explaining conveniently, the chemical compound of addressing is represented with its common name.
Prescription
| Imipenum | 250g is (with C 12H 17N 3O 4The S meter) |
| Cilastatin Sodium | 250g is (with C 16H 26N 2O 5The S meter) |
| Sodium bicarbonate | 10g |
| Packing | 1000 bottles |
Wherein imipenum is an antibacterial, and Cilastatin Sodium is the dehydropeptidase inhibitor, and sodium bicarbonate is an adjuvant, as solubilizing agent (increasing the dissolubility of imipenum) and PH regulator.
[0014]
Preparation technology
2.1 aseptic mixing
Like Fig. 1
2.2 the cleaning of cillin bottle, butyl rubber plug, aluminium-plastic cap and sterilization
Like Fig. 2
2.3 packing
Like Fig. 3
Should be noted that; The above is merely preferred embodiment of the present invention; Be not limited to scope of the present invention, all any modifications of within spirit of the present invention and principle, having done, the replacement that is equal to and improvement etc. all should be included within protection scope of the present invention.
Claims (3)
1. the preparation technology of an imipenem for injection Cilastatin Sodium, it may further comprise the steps:
(1) aseptic mixing
Cilastatin Sodium, imipenum and sodium bicarbonate are obtained aseptic imipenem cilastatin sodium mixing intermediate in 20 ~ 24 ℃ of local laminar flows mixing, and after check, mix homogeneously is for use;
(2) cleaning of cillin bottle, butyl rubber plug, aluminium-plastic cap and sterilization
After the ultrasound wave wash bottle, reuse purified water, water for injection flushing are subsequently through the sterilization in 5 minutes more than 350 ℃ of tunnel baking oven with cillin bottle;
Through ultrasonic waves for cleaning, 121 ℃ of steam sterilizations of warp are 30 minutes again with butyl rubber plug, and vacuum drying is 90 minutes subsequently, 120 ℃ of xeothermic 2h sterilizations;
Aluminium-plastic cap was through 120 ℃ of sterilizations 1.5 hours;
(3) packing
Aseptic imipenem cilastatin sodium mixing intermediate is obtained semi-finished product in 20 ~ 24 ℃ of local laminar flows, through lamp inspection, labeling, pack finished product to be checked, after the check certified products, the warehouse-in.
2. preparation technology as claimed in claim 1, wherein the mass ratio of imipenum and Cilastatin Sodium is 1:1.
3. preparation technology as claimed in claim 1, wherein imipenum: Cilastatin Sodium: the mass ratio of sodium bicarbonate is 1:1: (0.01-0.1).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011104547790A CN102579431A (en) | 2011-12-16 | 2011-12-30 | Preparation process of imipenem and cilastatin sodium for injection |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110422658.8 | 2011-12-16 | ||
| CN201110422658 | 2011-12-16 | ||
| CN2011104547790A CN102579431A (en) | 2011-12-16 | 2011-12-30 | Preparation process of imipenem and cilastatin sodium for injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102579431A true CN102579431A (en) | 2012-07-18 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN2011104547790A Pending CN102579431A (en) | 2011-12-16 | 2011-12-30 | Preparation process of imipenem and cilastatin sodium for injection |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106176722A (en) * | 2016-08-08 | 2016-12-07 | 天津青松华药医药有限公司 | A kind of imipenem for injection cilastatin sodium aseptic powdery preparation and preparation method thereof |
| CN109381434A (en) * | 2018-12-03 | 2019-02-26 | 瀚晖制药有限公司 | Imipenem for injection Cilastatin Sodium and its manufacture craft |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1568975A (en) * | 2004-04-28 | 2005-01-26 | 济南久创化学有限责任公司 | Preparing method of freeze-dried antibiotic formulation |
-
2011
- 2011-12-30 CN CN2011104547790A patent/CN102579431A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1568975A (en) * | 2004-04-28 | 2005-01-26 | 济南久创化学有限责任公司 | Preparing method of freeze-dried antibiotic formulation |
Non-Patent Citations (2)
| Title |
|---|
| 刘海洪: "药用丁基橡胶瓶塞灭菌方法汇总", 《世界橡胶工业》 * |
| 朱照镜: "《药剂学》", 30 June 2010, 科技出版社 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106176722A (en) * | 2016-08-08 | 2016-12-07 | 天津青松华药医药有限公司 | A kind of imipenem for injection cilastatin sodium aseptic powdery preparation and preparation method thereof |
| CN106176722B (en) * | 2016-08-08 | 2019-04-19 | 泊诺(天津)创新医药研究有限公司 | A kind of imipenem for injection cilastatin sodium aseptic powdery preparation and preparation method thereof |
| CN109381434A (en) * | 2018-12-03 | 2019-02-26 | 瀚晖制药有限公司 | Imipenem for injection Cilastatin Sodium and its manufacture craft |
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| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20120718 |