CN102772375A - Creatine phosphate sodium for injection and preparation method for creatine phosphate sodium for injection - Google Patents
Creatine phosphate sodium for injection and preparation method for creatine phosphate sodium for injection Download PDFInfo
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- CN102772375A CN102772375A CN201210302310XA CN201210302310A CN102772375A CN 102772375 A CN102772375 A CN 102772375A CN 201210302310X A CN201210302310X A CN 201210302310XA CN 201210302310 A CN201210302310 A CN 201210302310A CN 102772375 A CN102772375 A CN 102772375A
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Abstract
The invention discloses a method for preparing creatine phosphate sodium for injection. The method is characterized in that a creatine phosphate sodium nanosphere is prepared by adopting a high-frequency ultrasonic technology, pre-frozen by a spraying freeze dryer and dried by a microwave freeze dryer; a formula of the product is optimized; the treating effect of the product is enhanced; the stability of the product is improved; the production period is shortened; the cost is reduced; the quality of the product is guaranteed; and a satisfaction effect is achieved.
Description
Technical field
The present invention relates to the chemical drugs preparation field, be specifically related to a kind of injection Creatine Phosphate Sodium and preparation method thereof.
Background technology
Adding when Creatine Phosphate Sodium is usually used in operation on heart and protect the myocardial metabolism under the myocardial ischemia unusual in the cardioplegic solution, is a line medicine of treatment cardiovascular disease.The clinical Creatine Phosphate Sodium that uses is sterile packaged preparation mostly, and the preparation of its aseptic raw material powder is comparatively loaded down with trivial details, and long term store is prone to caking, and the back clarity of redissolving is unstable.Chinese invention patent CN2008101834128 discloses a kind of creatine phosphate sodium microballoon lyophilized preparation and production method thereof, has solved the problems referred to above preferably, but by the creatine phosphate sodium microballoon lyophilized preparation particle diameter of its method preparation between 150～300nm; Be difficult for through the histiocyte endothelium, organize Chinese medicine concentration lower beyond the blood circulation, affect the treatment; Exist envelop rate low excessively simultaneously; Deficiencies such as production cost is too high, and the production cycle is long, and keeping life is short.
Summary of the invention
The present invention adopts nanosphere technology and microwave freeze-dry technology for overcoming above-mentioned deficiency, and a kind of injection Creatine Phosphate Sodium and preparation method thereof is provided; Improve the product curative effect, shortened the production cycle, improved envelop rate; Reduce cost, increased product stability, obtained promising result.
The invention embodiment is following:
Get 30～50 parts in gelatin, 10～30 parts of arabic gums, 2～6 parts of sodium carboxymethyl cellulose are put in the Ultrasound Instrument, add 1000 parts of waters for injection, select supersonic frequency 30kHz, open agitating device, and ultrasonic dissolution 10 minutes gets clear and bright colloid solution; Add 20～40 parts of Creatine Phosphate Sodiums, 6～10 parts of glycerol, 2～4 parts in mannitol, 1～3 part of disodium edetate; Stirred 5 minutes, and pH value of solution was transferred to 6.8～7.2, with 0.22 μ m filtering with microporous membrane with the 1mol/L sodium hydroxide solution; Select supersonic frequency 300kHz, ultrasonic 30 minutes, get emulsion; Emulsion is put in the atomizing freeze drying machine, select spray chilling temperature-30 ℃, pressure 20Pa; Get the Creatine Phosphate Sodium ice crystal, ice crystal is put in the microwave freeze-dry machine, select microwave frequency 1450MHz; Temperature-50 ℃, pressure 12Pa, microwave distillation 3 hours down; Be warming up to 25 ℃, drying under reduced pressure 2 hours gets nanosphere product injection Creatine Phosphate Sodium.
The present invention program compares with prior art, and substantial characteristics and obvious improvement are:
1 selects high frequency ultrasound technology preparation Creatine Phosphate Sodium nanosphere for use, and envelop rate reaches more than 95%, and particle diameter reaches 30～50nm, is easy to improve the product curative effect through the endothelium of organizing outside the blood circulation, has increased product stability.
2 the present invention adopt the spraying freeze dryer to carry out pre-freeze, adopt the microwave freeze-dry machine to carry out drying, have shortened drying time, have reduced energy consumption.
3 the present invention have optimized formula for a product, and preferred capsule material, emulsifying agent, thickening agent, stabilizing agent, have increased the stability of product, and have reduced production cost.
Term related among the present invention program is all explained with medicine related specifications such as Chinese Pharmacopoeia, State Food and Drug Administration's standards to be as the criterion like no specified otherwise.
" part " described in the foregoing invention scheme refers to weight portion.
The power selection of equipment is confirmed according to the size of institute's production sample amount in the foregoing invention scheme, can realize the present invention by manufacturer's equipment specification regulation.
The raw material standard that above-mentioned embodiment is mentioned is following:
Creatine Phosphate Sodium: State Food and Drug Administration's drug standard;
Gelatin: Chinese Pharmacopoeia version two ministerial standards in 2010;
Arabic gum: Chinese Pharmacopoeia version two ministerial standards in 2010;
Sodium carboxymethyl cellulose: Chinese Pharmacopoeia version two ministerial standards in 2010;
Glycerol: Chinese Pharmacopoeia version two ministerial standards in 2010;
Mannitol: Chinese Pharmacopoeia version two ministerial standards in 2010;
Disodium edetate: Chinese Pharmacopoeia version two ministerial standards in 2010;
Sodium hydroxide: Chinese Pharmacopoeia version two ministerial standards in 2010;
Water for injection: Chinese Pharmacopoeia version two ministerial standards in 2010;
The used raw material of above injection Creatine Phosphate Sodium does not have specific (special) requirements, all can buy from pharmaceuticals to obtain, and all can be used to embodiment of the present invention as long as satisfy quality standard.
The key equipment that above-mentioned embodiment is mentioned is following:
Ultrasound Instrument: frequency 20kHz～400kHz, power 50～5000W;
(typical production manufacturer: the Beijing Hongxianglong Biotechnology Development Co., Ltd)
Microwave freeze-drying machine: frequency 900MHz～2450 MHz, power 100～5000W, temperature-30～-70 ℃;
(typical production manufacturer: the Yantai dragon rises the microwave technology company limited)
Atomizing freeze drying machine: spray chilling temperature-10 ℃～-50 ℃, vacuum pressure 2～40Pa, condenser temperature-20～-80 ℃;
(typical production manufacturer: Shanghai refined gift of money for a friend going on a journey device equipment company limited, the intercontinental environment-development drying equipment of Changzhou company limited)
The used equipment of above injection Creatine Phosphate Sodium does not have specific (special) requirements, and all there is sale in market, all can be used to embodiment of the present invention as long as satisfy parameter area.
Four specific embodiment
Specific embodiment 1 of the present invention
Get gelatin 30g, arabic gum 10g, sodium carboxymethyl cellulose 2g puts in the Ultrasound Instrument, adds 1000g water for injection, selects supersonic frequency 30kHz, opens agitating device, and ultrasonic dissolution 10 minutes gets clear and bright colloid solution; Add Creatine Phosphate Sodium 20g, glycerol 6g, mannitol 2g, disodium edetate 1g stirred 5 minutes, with the 1mol/L sodium hydroxide solution pH value of solution was transferred to 7.2, with 0.22 μ m filtering with microporous membrane, selected supersonic frequency 300kHz, ultrasonic 30 minutes, got emulsion; Emulsion is put in the atomizing freeze drying machine, selects spray chilling temperature-30 ℃, pressure 20Pa, the Creatine Phosphate Sodium ice crystal; Ice crystal is put in the microwave freeze-dry machine, selected microwave frequency 1450MHz, temperature-50 ℃; Pressure 12Pa, microwave distilled 3 hours down, was warming up to 25 ℃; Drying under reduced pressure 2 hours gets Creatine Phosphate Sodium nanosphere lyophilized powder, and packing is used for injection.
Specific embodiment 2 of the present invention
Get gelatin 50g, arabic gum 30g, sodium carboxymethyl cellulose 6g puts in the Ultrasound Instrument, adds 1000g water for injection, selects supersonic frequency 30kHz, opens agitating device, and ultrasonic dissolution 10 minutes gets clear and bright colloid solution; Add Creatine Phosphate Sodium 40g, glycerol 10g, mannitol 4g, disodium edetate 3g stirred 5 minutes, with the 1mol/L sodium hydroxide solution pH value of solution was transferred to 6.8, with 0.22 μ m filtering with microporous membrane, selected supersonic frequency 300kHz, ultrasonic 30 minutes, got emulsion; Emulsion is put in the atomizing freeze drying machine, selects spray chilling temperature-30 ℃, pressure 20Pa, the Creatine Phosphate Sodium ice crystal; Ice crystal is put in the microwave freeze-dry machine, selected microwave frequency 1450MHz, temperature-50 ℃; Pressure 12Pa, microwave distilled 3 hours down, was warming up to 25 ℃; Drying under reduced pressure 2 hours gets Creatine Phosphate Sodium nanosphere lyophilized powder, and packing is used for injection.
The preferred specific embodiment 3 of the present invention
Get gelatin 40g, arabic gum 20g, sodium carboxymethyl cellulose 4g puts in the Ultrasound Instrument, adds 1000g water for injection, selects supersonic frequency 30kHz, opens agitating device, and ultrasonic dissolution 10 minutes gets clear and bright colloid solution; Add Creatine Phosphate Sodium 30g, glycerol 8g, mannitol 3g, disodium edetate 2g stirred 5 minutes, with the 1mol/L sodium hydroxide solution pH value of solution was transferred to 7.0, with 0.22 μ m filtering with microporous membrane, selected supersonic frequency 300kHz, ultrasonic 30 minutes, got emulsion; Emulsion is put in the atomizing freeze drying machine, selects spray chilling temperature-30 ℃, pressure 20Pa, the Creatine Phosphate Sodium ice crystal; Ice crystal is put in the microwave freeze-dry machine, selected microwave frequency 1450MHz, temperature-50 ℃, pressure 12Pa; Microwave distilled 3 hours down, was warming up to 25 ℃, and drying under reduced pressure 2 hours gets Creatine Phosphate Sodium nanosphere lyophilized powder; Detection level, packing gets the injection Creatine Phosphate Sodium.
Above embodiment explanation adopts the extreme condition and the optimal conditions of embodiment of the present invention all can process the injection Creatine Phosphate Sodium, and the injection Creatine Phosphate Sodium that makes with embodiment 3 is below investigated actual effect of the present invention:
1 the present invention program prepares the injection Creatine Phosphate Sodium and prepares the contrast of injection Creatine Phosphate Sodium production cycle with adopting art methods.
Table 1 production cycle contrast table
The above results shows, the present invention prepares the injection Creatine Phosphate Sodium and significantly shortens than adopting art methods and prepare the injection Creatine Phosphate Sodium production cycle.
2 the present invention program prepare the injection Creatine Phosphate Sodium and prepare the contrast of injection Creatine Phosphate Sodium production cost with adopting art methods.
Table 2 production cost contrast table
The above results shows, the present invention prepares the injection Creatine Phosphate Sodium and significantly reduces than adopting art methods and preparing injection Creatine Phosphate Sodium production cost.
3 the present invention program prepare the injection Creatine Phosphate Sodium and prepare the contrast of injection Creatine Phosphate Sodium envelop rate with adopting Chinese invention patent CN2008101834128 method.
Table 3 envelop rate contrast table
The above results shows; The present invention program prepares injection Creatine Phosphate Sodium nanosphere and adopts Chinese invention patent CN2008101834128 method to prepare injection creatine phosphate sodium microballoon envelop rate to improve a lot; Thereby improved product quality; Increase product yield, further reduce production costs.
4 the present invention program prepare the injection Creatine Phosphate Sodium and adopt the contrast of prior art for preparing injection phosphorus creatine acid stable sodium property.
Method:
Get the injection phosphorus creatine acid sodium sample of the present invention program's preparation and the injection phosphorus creatine acid sodium sample of prior art for preparing and place 25 ℃ ± 2 ℃ of temperature; In RH60% ± 10% environment; In the 0th, 3,6,9,12,18,24,36 sampling at the end of month, detect according to injection Creatine Phosphate Sodium standards project.
The result:
Table 4 effect duration contrast table
The above results shows that the present invention prepares the injection Creatine Phosphate Sodium than adopting prior art for preparing injection Creatine Phosphate Sodium expiry date significant prolongation, and stability increases.
5 the present invention program prepare the injection Creatine Phosphate Sodium and prepare the contrast of injection Creatine Phosphate Sodium particle diameter with adopting Chinese invention patent CN2008101834128 method.
Method:
Get the injection Creatine Phosphate Sodium,, adopt current potential particle diameter appearance to observe record with the water for injection dissolving.
The result:
Table 5 particle diameter contrast table
The above results shows; The present invention prepares the injection Creatine Phosphate Sodium and reduces than adopting Chinese invention patent CN2008101834128 method and preparing injection Creatine Phosphate Sodium particle diameter, be easy to through blood circulation outer organize endothelium, get into tissue fluid; Improve the product curative effect, increased product stability.
6 the present invention program prepare the injection Creatine Phosphate Sodium and prepare injection Creatine Phosphate Sodium Comparison of therapeutic with adopting Chinese invention patent CN2008101834128 method.
Method:
Get 12 of quality 190～210gWistar rats, be divided into 2 groups at random, fasting can't help water 12 hours; The Creatine Phosphate Sodium and the injection Creatine Phosphate Sodium that adopts the preparation of the Chinese CN2008101834128 of invention method of difference intravenous injection same dose the present invention program preparation, disconnected neck is put to death and is respectively organized rat after 30 minutes, separation cardiac muscular tissue; Be cut into small pieces, ice bath homogenate 1 minute, centrifugal; Get supernatant, carry out efficient liquid phase chromatographic analysis.
Table 6 mouse tissue liquid Chinese medicine concentration contrast table
The above results shows; The present invention prepares the injection Creatine Phosphate Sodium and prepares the outer tissue fluid Chinese medicine concentration rising of injection Creatine Phosphate Sodium blood circulation than adopting Chinese invention patent CN2008101834128 method; And the modern pharmacology science shows; Drug level and curative effect are proportional, and therefore, product of the present invention strengthens than the product curative effect of prior art for preparing.
The injection Creatine Phosphate Sodium safety testing of 7 the present invention program preparation.
Method:
" chemicals zest, anaphylaxis and hemolytic investigative technique guideline " appended method of appendix of announcing according to State Food and Drug Administration makes an experiment.
The result:
The injection Creatine Phosphate Sodium nonirritant reaction of the present invention program's preparation, no anaphylactic reaction, no hemolytic reaction acts on safe and reliable.
Claims (3)
1. an injection Creatine Phosphate Sodium is characterized in that adopting following method preparation: get 30～50 parts in gelatin, 10～30 parts of arabic gums; 2～6 parts of sodium carboxymethyl cellulose are put in the Ultrasound Instrument, add 1000 parts of waters for injection; Select supersonic frequency 30kHz; Open agitating device, ultrasonic dissolution 10 minutes gets clear and bright colloid solution; Add 20～40 parts of Creatine Phosphate Sodiums, 6～10 parts of glycerol, 2～4 parts in mannitol, 1～3 part of disodium edetate; Stirred 5 minutes, and pH value of solution was transferred to 6.8～7.2, with 0.22 μ m filtering with microporous membrane with the 1mol/L sodium hydroxide solution; Select supersonic frequency 300kHz, ultrasonic 30 minutes, get emulsion; Emulsion is put in the atomizing freeze drying machine, select spray chilling temperature-30 ℃, pressure 20Pa; Get the Creatine Phosphate Sodium ice crystal, ice crystal is put in the microwave freeze-dry machine, select microwave frequency 1450MHz; Temperature-50 ℃, pressure 12Pa, microwave distillation 3 hours down; Be warming up to 25 ℃, drying under reduced pressure 2 hours gets the injection Creatine Phosphate Sodium.
2. according to the method for preparing of claim 1 said injection Creatine Phosphate Sodium, it is characterized in that getting 30～50 parts in gelatin, 10～30 parts of arabic gums; 2～6 parts of sodium carboxymethyl cellulose are put in the Ultrasound Instrument, add 1000 parts of waters for injection; Select supersonic frequency 30kHz; Open agitating device, ultrasonic dissolution 10 minutes gets clear and bright colloid solution; Add 20～40 parts of Creatine Phosphate Sodiums, 6～10 parts of glycerol, 2～4 parts in mannitol, 1～3 part of disodium edetate; Stirred 5 minutes, and pH value of solution was transferred to 6.8～7.2, with 0.22 μ m filtering with microporous membrane with the 1mol/L sodium hydroxide solution; Select supersonic frequency 300kHz, ultrasonic 30 minutes, get emulsion; Emulsion is put in the atomizing freeze drying machine, select spray chilling temperature-30 ℃, pressure 20Pa; Get the Creatine Phosphate Sodium ice crystal, ice crystal is put in the microwave freeze-dry machine, select microwave frequency 1450MHz; Temperature-50 ℃, pressure 12Pa, microwave distillation 3 hours down; Be warming up to 25 ℃, drying under reduced pressure 2 hours makes the injection Creatine Phosphate Sodium.
3. according to the method for preparing of claim 1 said injection Creatine Phosphate Sodium, it is characterized in that getting 40 parts in gelatin, 20 parts of arabic gums; 4 parts of sodium carboxymethyl cellulose are put in the Ultrasound Instrument, add 1000 parts of waters for injection; Select supersonic frequency 30kHz; Open agitating device, ultrasonic dissolution 10 minutes gets clear and bright colloid solution; Add Creatine Phosphate Sodium 30g, glycerol 8g, mannitol 3g, disodium edetate 2g stirred 5 minutes, with the 1mol/L sodium hydroxide solution pH value of solution was transferred to 7.0, with 0.22 μ m filtering with microporous membrane, selected supersonic frequency 300kHz, ultrasonic 30 minutes, got emulsion; Emulsion is put in the atomizing freeze drying machine, selects spray chilling temperature-30 ℃, pressure 20Pa, the Creatine Phosphate Sodium ice crystal; Ice crystal is put in the microwave freeze-dry machine, selected microwave frequency 1450MHz, temperature-50 ℃, pressure 12Pa; Microwave distilled 3 hours down, was warming up to 25 ℃, and drying under reduced pressure 2 hours gets Creatine Phosphate Sodium nanosphere lyophilized powder; Detection level, packing gets the injection Creatine Phosphate Sodium.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103405400A (en) * | 2013-08-30 | 2013-11-27 | 孙威 | Levosulpiride injection and preparation method thereof |
| CN114557969A (en) * | 2022-02-18 | 2022-05-31 | 海南久常制药有限公司 | Creatine phosphate sodium powder injection for injection and preparation method thereof |
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| CN101313910A (en) * | 2007-05-31 | 2008-12-03 | 上海慈瑞医药科技有限公司 | Preparation technique for sodium phosphocreatine freeze-dried injection |
| CN101474159A (en) * | 2008-12-16 | 2009-07-08 | 海南美大制药有限公司 | Creatine phosphate sodium microballoon lyophilized preparation and method for producing the same |
| CN101732263A (en) * | 2008-11-14 | 2010-06-16 | 杨军 | Creatine phosphate sodium freeze-dried preparation and method for preparing same |
| CN102525962A (en) * | 2012-01-17 | 2012-07-04 | 山东罗欣药业股份有限公司 | Power injection for injecting creatine phosphate sodium composition |
-
2012
- 2012-08-23 CN CN 201210302310 patent/CN102772375B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101313910A (en) * | 2007-05-31 | 2008-12-03 | 上海慈瑞医药科技有限公司 | Preparation technique for sodium phosphocreatine freeze-dried injection |
| CN101732263A (en) * | 2008-11-14 | 2010-06-16 | 杨军 | Creatine phosphate sodium freeze-dried preparation and method for preparing same |
| CN101474159A (en) * | 2008-12-16 | 2009-07-08 | 海南美大制药有限公司 | Creatine phosphate sodium microballoon lyophilized preparation and method for producing the same |
| CN102525962A (en) * | 2012-01-17 | 2012-07-04 | 山东罗欣药业股份有限公司 | Power injection for injecting creatine phosphate sodium composition |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103405400A (en) * | 2013-08-30 | 2013-11-27 | 孙威 | Levosulpiride injection and preparation method thereof |
| CN114557969A (en) * | 2022-02-18 | 2022-05-31 | 海南久常制药有限公司 | Creatine phosphate sodium powder injection for injection and preparation method thereof |
| CN114557969B (en) * | 2022-02-18 | 2023-04-18 | 海南久常制药有限公司 | Creatine phosphate sodium powder injection for injection and preparation method thereof |
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| CN102772375B (en) | 2013-07-17 |
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Application publication date: 20121114 Assignee: HEBEI TIANCHENG PHARMACEUTICAL CO., LTD. Assignor: Sun Wei Contract record no.: 2013990000490 Denomination of invention: Creatine phosphate sodium for injection and preparation method for creatine phosphate sodium for injection Granted publication date: 20130717 License type: Common License Record date: 20130814 |
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Assignee: HEBEI TIANCHENG PHARMACEUTICAL CO., LTD. Assignor: Sun Wei Contract record no.: 2013990000490 Date of cancellation: 20150105 |
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Application publication date: 20121114 Assignee: HEBEI TIANCHENG PHARMACEUTICAL CO., LTD. Assignor: Sun Wei Contract record no.: 2015990000008 Denomination of invention: Creatine phosphate sodium for injection and preparation method for creatine phosphate sodium for injection Granted publication date: 20130717 License type: Common License Record date: 20150105 |
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Effective date of registration: 20170919 Address after: 150025 No. 13 Beijing Road, Limin Development Zone, Heilongjiang, Harbin Patentee after: HARBIN LAIBOTEN PHARMACEUTICAL CO., LTD. Address before: 710 room 90, No. 150000, Xiangjiang Road, Harbin Development Zone, Heilongjiang, China Patentee before: Sun Wei |