CN101780032A - Clindamycin phosphate injection preparation and preparation method thereof - Google Patents
Clindamycin phosphate injection preparation and preparation method thereof Download PDFInfo
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- CN101780032A CN101780032A CN200910005011A CN200910005011A CN101780032A CN 101780032 A CN101780032 A CN 101780032A CN 200910005011 A CN200910005011 A CN 200910005011A CN 200910005011 A CN200910005011 A CN 200910005011A CN 101780032 A CN101780032 A CN 101780032A
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- clindamycin phosphate
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- injection
- prescription
- phosphate injection
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Abstract
The invention provides a clindamycin phosphate injection preparation and a prescription thereof. According to the prescription, the clindamycin phosphate injection preparation comprises clindamycin phosphate, a cosolvent, a metal ion complexing agent, a solvent of raw materials and auxiliary materials and the like. The invention aims to provide a method for preparing the clindamycin phosphate injection preparation with more advanced technology and better product quality.
Description
Technical field
The invention belongs to pharmaceutical preparation, relate to chemical semisynthetic clindamycin derivative formulations and preparation method, relate in particular to clindamycin phosphate injection preparation and preparation method thereof.
Background technology
Clindamycin phosphate belongs to lincomycin class semisynthetic antibiotics.In like product, fat-soluble, the permeability of clindamycin phosphate all are better than clindamycin, particularly overcome Clindamycin Hydrochloride and in the intramuscular injection process, caused the shortcoming that has an intense pain, thereby be present only this type of injection kind of being recorded by the pharmacopeia of state and Britain.
Clindamycin phosphate injection has packaging material and two kinds of technologies, i.e. ampoule bottle and cillin bottle in two kinds at present.Present most producer is an ampoule bottle, and the cillin bottle clindamycin phosphate injection that my company produces is domesticly only to have, and its characteristics are as follows:
1, adopt international up-to-date injection technology of preparing---heat sterilization, when having avoided heat sterilization to the influence of composition.The main difficult technical of producing clindamycin phosphate injection also promptly is sterilization.Adopt 115 ℃ of following high temperature sterilizes of 30 minutes by injection, temperature is minimum also should be more than 105 ℃, if adopt the high temperature sterilize more than 100 ℃.Principal agent composition clindamycin phosphate (ester type compound) ester ring crack is separated, and related substance exceeds standard, and pH value is reduced to below 3.5.The injection pH value is lower than 3.5 easily can cause untoward reaction such as acidosis---and this is bigger, more direct than the not enough harm of sterilization.If reduce sterilising temp and shorten sterilization time, for example, glad sterilising temp and the time not only is 99.5 degree and four minutes, and it is not thorough, aseptic defective to occur sterilizing.Adopt heat sterilization to prepare clindamycin phosphate injection and avoided above shortcoming.
2, introduce external sophisticated equipment, hundred grades purify fill under the rank.The general bottled injection packing under ten thousand grades at most of ampoule.And employing flame sealing.Easily make the debris ratio become visible granular and produce relative negative pressure simultaneously.When opening ampoule bottle, have the risk that microgranule enters.
3, use the import medical rubber plug (half coating technology) of the Western-style enterprise of the U.S..Extremely strong with medicinal liquid contact portion inertia, with interior packaging material contact portion plated film not, make its contact tightr, do not have the risk of pine lid and gas leakage.
Compare with the ampoule bottle liquid drugs injection
4, the ampoule bottle liquid drugs injection adopts final sterilization, and this is to the picture crin ... the medicine of .. such case of thermal instability easily decomposes in the process of sterilization, and related substance improves, and is the ultrafiltration sterilization and the cillin bottle liquid drugs injection adopts, carries out that medicine is not had influence under hundred grades of room temperature.
Adopt elevated temperature heat to relative negative pressure in the bottle when 5, ampoule bottle seals, the bottleneck debris is easily burnt, and this visible foreign matters when uncork increases, and the cillin bottle liquid drugs injection is that packing adds the generation that half coating is definitely kept away this type of phenomenon under hundred grades.
6, compare with the lyophilizing pin
(1) in the lyophilizing pin process of reproduction, temperature rises more than+30 degree by-40 degree, and temperature span nearly 70 is spent, and be unavoidable to the stability influence of medicine, and the cillin bottle liquid drugs injection is to produce at normal temperatures.
(2) the lyophilizing pin is again during dosing, and add a certain amount of mannitol etc. and do skeleton, though mannitol is less to the principal agent influence, also be that therapeutical effect is arranged, only untoward reaction just has nine more than, and the cillin bottle liquid drugs injection need not add this type of material.
Need increase the chance of primary pollution medicinal liquid with adopting and to use after the solvent dissolving when (3) the lyophilizing pin uses; The cillin bottle liquid drugs injection is directly packed into and just can be injected, and has avoided polluting once more, uses safer.
Summary of the invention
It is more advanced to the purpose of this invention is to provide a kind of technology, the prescription of the better clindamycin phosphate injection of product quality and preparation method.
Clindamycin phosphate injection prescription provided by the invention, its prescription consists of:
Clindamycin phosphate 91.1%～93.5%
Cosolvent 6.2%～8.0%
Complexing of metal ion agent 0.3%～0.4%
Solvent 2000ml～the 10000ml of former, adjuvant
Cosolvent can be selected benzyl alcohol
The complexing of metal ion agent can be selected disodium edetate
Solvent former, adjuvant can be selected water for injection
Clindamycin phosphate provided by the invention injection preparation method: (1) cillin bottle, plug, plastic-aluminum composite cover washing and sterilizing (2) dosing: take by weighing the benzyl alcohol of recipe quantity and disodium edetate in Agitation Tank, the water for injection that adds recipe quantity 30%, stirring and dissolving.Take by weighing the clindamycin phosphate of recipe quantity, alternately be added to whole dissolvings, stir with 5% sodium hydroxide solution.With the hydrochloric acid solution adjust pH of 1mol/L is to add to the full amount of water for injection after between 5.8～6.2, stirs.(3) charcoal absorption: add the active carbon of 0.03% (g/ml), 30 minutes after-filtration of stirring at room take off charcoal.(4) product detect in the middle of: measure clindamycin phosphate content, pH value.(5) use ultrafilter heat sterilization (6) fill under aseptic condition: hundred grades purify fill under the ranks.(7) tamponade: adopt the semi-coating medical rubber plug tamponade.(8) lamp inspection, labeling, packing.
Technical characterstic of the present invention is the little adjuvant of prescription-employing untoward reaction, and preparation-employing XiLin is bottled, sterilization-employing ultrafilter heat sterilization, fill-purify fill under the rank, plug-employing semi-coating medical rubber plug at hundred grades.Its preparation method advanced person, more stable quality is fit to suitability for industrialized production.
The specific embodiment:
The invention will be further described with by way of example more below, provides the present invention and get implementation detail, but be not to be intended to limit protection scope of the present invention.
Embodiment 1
Prescription: clindamycin phosphate 356.6g
Benzyl alcohol 20g
Disodium edetate 1g
Water for injection adds to 2000ml
Make 1000
Preparation method:
1. the cleaning of control antibiotic glass bottle, sterilization
The control antibiotic glass bottle is removed through outer package, imports bottle into and washes between baking, through bottle washer cleaning, 320 ℃ of hot blasts sterilizations of dry sterilizer 6 minutes, cooling.
2. the cleaning of butyl rubber bung, sterilization
Butyl rubber bung is removed through outer package, and rubber plug cleaning machine cleans, 121 ℃ of dry heat sterilizations 120 minutes, and cooling, standby.
3. the sterilization of plastic-aluminum composite cover
Aluminium-plastic cap is removed through outer package, imports that aluminium-plastic cap cleans into, between sterilization, 110 ℃ of dry heat sterilizations 120 minutes, and cooling, standby.
4. dosing:
Take by weighing the benzyl alcohol of recipe quantity and disodium edetate in Agitation Tank, add the water for injection of recipe quantity 30%, stirring and dissolving.Take by weighing the clindamycin phosphate of recipe quantity, alternately be added to whole dissolvings, stir with 5% sodium hydroxide solution.With the hydrochloric acid solution adjust pH of 1mol/L is to add to the full amount of water for injection after between 5.8～6.2, stirs.
5. charcoal absorption: add the active carbon of 0.03% (g/ml), stirring at room 30 minutes is filtered carbon removal with the titanium rod.
6. product detect in the middle of: measure clindamycin phosphate content, pH value.
7. degerming
Under aseptic condition, use the ultrafilter heat sterilization
8. fill, tamponade
It is qualified that filtrate content, pH value, clarity detect, and fill is pressed plug entirely in the cillin bottle bottle
9. roll lid
Fill and the intact sample of tamponade imported into to roll roll lid between lid.
10. lamp inspection, outsourcing
The intact sample of lid be will roll and lamp inspection, labeling and packing carried out respectively.
Embodiment 2
Prescription: clindamycin phosphate 1069.8g
Benzyl alcohol 100g
Disodium edetate 5g
Water for injection adds to 10000ml
Make 1000
Preparation method:
1. the cleaning of control antibiotic glass bottle, sterilization
The control antibiotic glass bottle is removed through outer package, imports bottle into and washes between baking, through bottle washer cleaning, 320 ℃ of hot blasts sterilizations of dry sterilizer 6 minutes, cooling.
2. the cleaning of butyl rubber bung, sterilization:
Butyl rubber bung is removed through outer package, and rubber plug cleaning machine cleans, 121 ℃ of dry heat sterilizations 120 minutes, and cooling, standby.
3. the sterilization of plastic-aluminum composite cover:
Aluminium-plastic cap is removed through outer package, imports that aluminium-plastic cap cleans into, between sterilization, 110 ℃ of dry heat sterilizations 120 minutes, and cooling, standby.
4. dosing:
Take by weighing the benzyl alcohol of recipe quantity and disodium edetate in Agitation Tank, add the water for injection of recipe quantity 30%, stirring and dissolving.Take by weighing the clindamycin phosphate of recipe quantity, alternately be added to whole dissolvings, stir with 5% sodium hydroxide solution.With the hydrochloric acid solution adjust pH of 1mol/L is to add to the full amount of water for injection after between 5.8～6.2, stirs.
5. charcoal absorption:
The active carbon that adds 0.03% (g/ml), stirring at room 30 minutes is filtered carbon removal with the titanium rod.
6. product detect in the middle of
Measure clindamycin phosphate content, pH value.
7. degerming:
Under aseptic condition, use the ultrafilter heat sterilization
8. fill, tamponade:
It is qualified that filtrate content, pH value, clarity detect, and fill is pressed plug entirely in the cillin bottle bottle
9. roll lid:
Fill and the intact sample of tamponade imported into to roll roll lid between lid.
10. lamp inspection, outsourcing:
The intact sample of lid be will roll and lamp inspection, labeling and packing carried out respectively.
After having read above-mentioned teachings of the present invention, those skilled in the art can make various changes or modification to the present invention, and these equivalent form of values fall within the application's appended claims institute limited range equally.
Claims (5)
1. the prescription of a clindamycin phosphate injection and preparation method, its prescription consists of:
Clindamycin phosphate 91.1%～93.5%
Cosolvent 6.2%～8.0%
Complexing of metal ion agent 0.3%～0.4%
Solvent 2000ml～the 10000ml of former, adjuvant
2. clindamycin phosphate injection prescription as claimed in claim 1, it is characterized in that: cosolvent can be selected benzyl alcohol
3. clindamycin phosphate injection prescription as claimed in claim 1, it is characterized in that: the complexing of metal ion agent can be selected disodium edetate
4. clindamycin phosphate injection prescription as claimed in claim 1, it is characterized in that: solvent former, adjuvant can be selected water for injection
5. the preparation method of clindamycin phosphate injection preparation as claimed in claim 1 is characterized in that:
1. interior packaging material
Employing XiLin is bottled.
2. sterilization
Under aseptic condition, adopt the ultrafilter heat sterilization
3. fill
Purify fill under the rank at hundred grades
4. tamponade
Adopt semi-coating medical rubber plug
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910005011A CN101780032A (en) | 2009-01-16 | 2009-01-16 | Clindamycin phosphate injection preparation and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910005011A CN101780032A (en) | 2009-01-16 | 2009-01-16 | Clindamycin phosphate injection preparation and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
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| CN101780032A true CN101780032A (en) | 2010-07-21 |
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| CN200910005011A Pending CN101780032A (en) | 2009-01-16 | 2009-01-16 | Clindamycin phosphate injection preparation and preparation method thereof |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102258488A (en) * | 2011-07-19 | 2011-11-30 | 江苏奥赛康药业有限公司 | Clindamycin phosphate composition for injection and preparation method thereof |
| CN103110514A (en) * | 2011-11-17 | 2013-05-22 | 成都欣捷高新技术开发有限公司 | Preparation method for clindamycin phosphate injection liquid |
| CN104095809A (en) * | 2014-07-19 | 2014-10-15 | 成都天台山制药有限公司 | Pharmaceutical composition of clindamycin phosphate injection and preparation method |
| CN105310979A (en) * | 2015-10-30 | 2016-02-10 | 江苏大红鹰恒顺药业有限公司 | Clindamycin phosphate injection and preparation method thereof |
| CN105434453A (en) * | 2015-01-19 | 2016-03-30 | 武汉大安制药有限公司 | Clindamycin phosphate pharmaceutical composition for injection and preparation method thereof |
| CN111329835A (en) * | 2018-12-19 | 2020-06-26 | 山东威智百科药业有限公司 | Clindamycin phosphate injection and preparation method thereof |
-
2009
- 2009-01-16 CN CN200910005011A patent/CN101780032A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102258488A (en) * | 2011-07-19 | 2011-11-30 | 江苏奥赛康药业有限公司 | Clindamycin phosphate composition for injection and preparation method thereof |
| CN102258488B (en) * | 2011-07-19 | 2012-10-31 | 江苏奥赛康药业股份有限公司 | Clindamycin phosphate composition for injection and preparation method thereof |
| CN103110514A (en) * | 2011-11-17 | 2013-05-22 | 成都欣捷高新技术开发有限公司 | Preparation method for clindamycin phosphate injection liquid |
| CN104095809A (en) * | 2014-07-19 | 2014-10-15 | 成都天台山制药有限公司 | Pharmaceutical composition of clindamycin phosphate injection and preparation method |
| CN104095809B (en) * | 2014-07-19 | 2016-08-03 | 成都天台山制药有限公司 | Clindamycin phosphate injection pharmaceutical composition and preparation method |
| CN105434453A (en) * | 2015-01-19 | 2016-03-30 | 武汉大安制药有限公司 | Clindamycin phosphate pharmaceutical composition for injection and preparation method thereof |
| CN105434453B (en) * | 2015-01-19 | 2018-05-25 | 武汉大安制药有限公司 | A kind of clindamycin phosphate for injection pharmaceutical composition and preparation method thereof |
| CN105310979A (en) * | 2015-10-30 | 2016-02-10 | 江苏大红鹰恒顺药业有限公司 | Clindamycin phosphate injection and preparation method thereof |
| CN111329835A (en) * | 2018-12-19 | 2020-06-26 | 山东威智百科药业有限公司 | Clindamycin phosphate injection and preparation method thereof |
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Open date: 20100721 |