CN101579308A - Preparation process for clindamycin phosphate injection - Google Patents
Preparation process for clindamycin phosphate injection Download PDFInfo
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- CN101579308A CN101579308A CNA2009100160796A CN200910016079A CN101579308A CN 101579308 A CN101579308 A CN 101579308A CN A2009100160796 A CNA2009100160796 A CN A2009100160796A CN 200910016079 A CN200910016079 A CN 200910016079A CN 101579308 A CN101579308 A CN 101579308A
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- sterilization
- clindamycin phosphate
- injection
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention provides a preparation process for clindamycin phosphate injection. A method for controlling the pH value is adopted for increasing the solubility. The production process adopts a sterilization production process. A mode of combining ultrafiltration and sterilization filtration is adopted for eliminating pyrogen and sterilizing during production. Simultaneously the filling environment is a partial hundred grade in ten-thousand sterilization background, and the total sterilization operation is adopted in the production process, so that the pollution of environment and personnel is effectively prevented, and the sterility assurance level the same as that of the traditional sterilization process is obtained. In addition, the preparation process has the advantages of overcoming the defect of easy decomposition in high temperature and effectively ensuring the quality.
Description
Technical field
The invention belongs to medical technical field, particularly relate to a kind of preparation technology of clindamycin phosphate injection.
Background technology
Clindamycin phosphate is chemical semisynthetic clindamycin derivant, and it is in external no antibiotic activity, enters to be hydrolyzed to clindamycin rapidly behind the body and to show its pharmacologically active.So antimicrobial spectrum, antibacterial activity and therapeutic effect are identical with clindamycin, but its fat-soluble and permeability is better than crin mycin, but intramuscular injection and intravenous drip administration.Compare this product antibacterial action with lincomycin strong 4～8 times, good absorbing, bone concentration height and anaerobic infection had good curative effect.This product mainly has very strong antibacterial activity to gram positive coccus and anaerobe, comprises gram positive coccus: staphylococcus aureus, staphylococcus epidermidis, streptococcus (except the phosphorus streptococcus), streptococcus pneumoniae, Micrococcus etc.; Anaerobe: Clostridium, Bacteroides, bacillus fusiformis genus, propionibacterium, Eubacterium, anaerobic cocci etc.
The solvability of clindamycin phosphate in water is limited, decomposes easily under hot conditions simultaneously.
Summary of the invention
The inventor provides a kind of preparation technology of clindamycin phosphate injection, and its technical essential is:
A control injection pH value;
Add needle-use activated carbon absorption in the B medicinal liquid;
The C ultrafiltration combines with aseptic filtration.
Purpose is by the screening of process conditions, and definite solid element that influences the related substance of clindamycin phosphate injection is also controlled.Method is investigated 10,20,30,40 ℃ preparation temperature respectively; 0%, 0.1%, 0.2%, 0.4% active carbon; 80,100 ℃ sterilising temp; The molecular retention amount is the influences to the clindamycin phosphate injection related substance of four kinds of different process conditions of ultrafiltration of 10000.The result is with the rising of preparation temperature, and related substance raises, and rises to 40 ℃ from 10 ℃, and related substance raises about 1%; Related substance raises with the active carbon ratio, falls afterwards earlier to rise, and amounts of activated carbon is controlled at the 0.1%～0.2% more suitable of cumulative volume; Related substance rose about 3.6% and 10% respectively before 80 ℃, the 100 ℃ 20min that sterilize respectively sterilized; The molecular retention amount is that 10000 ultrafiltration can make this product related substance reduce about 0.3%.The above four kinds of process conditions of conclusion have in various degree influence to the related substance of clindamycin phosphate injection respectively, and wherein temperature is a key influence factor.
At air purity is under the hundred grades of conditions in full chamber, earlier a certain amount of clindamycin phosphate raw material is dissolved in water for injection, keep pH value between 6.0～6.4, stir evenly, be settled to the concentration of liquid medicine injection with water for injection,, use 0.45 μ m microporous filter membrane or corresponding filter cartridge coarse filtration then the needle-use activated carbon absorption that adds 0.05% in the medicinal liquid, with 0.22 μ m microporous filter membrane or the degerming of corresponding filter cartridge fine straining, filling and sealing promptly gets this finished product injection under hundred grades of conditions again.Because the present invention is in aseptic condition always, therefore need not final sterilization, do not increase the impurity of product when assurance is aseptic so again, thereby solved the defective of traditional clindamycin phosphate injection production technology, overcome the shortcoming that high temperature decomposes easily simultaneously, product quality is higher than the world and national standard.
The specific embodiment
Embodiment 1:
Clindamycin phosphate 357g (being equivalent to clindamycin 300g)
Water for injection 2000ml
Adopt the method for control pH value to increase dissolubility, production technology adopts aseptic explained hereafter, mode depyrogenation and the degerming of adopting ultrafiltration to combine in the production with aseptic filtration, filling environment is ten thousand grades of local laminar flows under the aseptic background simultaneously, whole sterile workings have effectively avoided environment and personnel's pollution in the production process, have reached the aseptic assurance level the same with traditional sterilization process, overcome the shortcoming that high temperature decomposes easily simultaneously, effectively guaranteed quality.
Claims (2)
1, a kind of preparation technology of clindamycin phosphate injection is characterized in that:
A. control the injection pH value,
B. add needle-use activated carbon absorption in the medicinal liquid,
C. ultrafiltration combines with aseptic filtration.
2, preparation technology according to claim 1 is characterized in that: control injection pH value is 6.0～6.4.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2009100160796A CN101579308A (en) | 2009-06-24 | 2009-06-24 | Preparation process for clindamycin phosphate injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2009100160796A CN101579308A (en) | 2009-06-24 | 2009-06-24 | Preparation process for clindamycin phosphate injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101579308A true CN101579308A (en) | 2009-11-18 |
Family
ID=41361717
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2009100160796A Pending CN101579308A (en) | 2009-06-24 | 2009-06-24 | Preparation process for clindamycin phosphate injection |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101579308A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109771371A (en) * | 2019-03-19 | 2019-05-21 | 安徽联谊药业股份有限公司 | A kind of clindamycin phosphate injection and preparation method thereof |
-
2009
- 2009-06-24 CN CNA2009100160796A patent/CN101579308A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109771371A (en) * | 2019-03-19 | 2019-05-21 | 安徽联谊药业股份有限公司 | A kind of clindamycin phosphate injection and preparation method thereof |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20091118 |