CN102908360A - Glycerin fructose sodium chloride injection and preparation process thereof - Google Patents
Glycerin fructose sodium chloride injection and preparation process thereof Download PDFInfo
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- CN102908360A CN102908360A CN201110220697XA CN201110220697A CN102908360A CN 102908360 A CN102908360 A CN 102908360A CN 201110220697X A CN201110220697X A CN 201110220697XA CN 201110220697 A CN201110220697 A CN 201110220697A CN 102908360 A CN102908360 A CN 102908360A
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- sodium chloride
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Abstract
The invention discloses a glycerin fructose sodium chloride injection and a preparation process thereof. According to the invention, the preparation method of the glycerin fructose sodium chloride injection comprises the following steps: preparing 50-150 parts of glycerin, 5-15 parts of sodium chloride and 10-100 parts of injection fructose by weight at a low temperature; and ultra-filtering a prepared product, wherein the low temperature is 30-60 DEG C. As the glycerin fructose sodium chloride injection disclosed by the invention is prepared by using a new technology and using a novel low temperature preparation and ultrafiltration technology, and any auxiliary material and active carbon are not needed in the preparation process, the instability problem of the fructose (5-hydroxymethyl furfural is generated) and the safety problem of active carbon residue are solved, and clinical potential safety hazards are eliminated.
Description
Technical field
The present invention relates to a kind of injection and preparation technology thereof, particularly a kind of Mannitol sodium chloride injection and preparation technology thereof.
Background technology
Mannitol sodium chloride injection belongs to clinically and falls the intracranial pressure medicine, and determined curative effect is firmly got doctor and patient's favorable comment.But because that this variety and quality requires is very high, wherein limiting the quantity of of 5 hydroxymethyl furfural requires extremely sternly, all adopts in the practice to add a certain amount of antioxidant and adjuvant solves this problem, can bring certain adjuvant safety issue like this; For the requirement of intravenously administrable, need to decolour with a large amount of active carbons and the removal of impurity simultaneously, because active carbon can not remove fully and stay in the injection, can locate the potential safety hazards such as gathering, formation granuloma at patient's blood vessel etc. like this.
Summary of the invention
The object of the invention is to provide a kind of Mannitol sodium chloride injection and preparation technology thereof, to overcome above-mentioned technological deficiency.
The present invention seeks to be achieved through the following technical solutions:
A kind of Mannitol sodium chloride injection, by the following method preparation: glycerol 50-150 weight portion, sodium chloride 5-15 weight portion, fructose for injection 10-100 weight portion are adopted low temperature preparation, ultra-filtration filters; Wherein low temperature refers to 30 ℃--60 ℃; Inject water to 1000 parts by volume.
In the Mannitol sodium chloride injection of the present invention, preferred 35 ℃, 40 ℃, 45 ℃, 50 ℃ or 55 ℃ of low temperature.
In the Mannitol sodium chloride injection of the present invention, ultra-filtration filters refers to 0.45um or 0.22um filtering with microporous membrane and/or ultrafiltration membrance filter.
In the Mannitol sodium chloride injection of the present invention, preferably glycerine 100 weight portions, sodium chloride 9 weight portions, fructose for injection 50 weight portions; Glycerol 20 weight portions, sodium chloride 12 weight portions, fructose for injection 15 weight portions; Perhaps glycerol 165 weight portions, sodium chloride 3 weight portions, fructose for injection 95 weight portions.
The relevant of weight portion/parts by volume of the present invention is g/ml.
Mannitol sodium chloride injection of the present invention falls application in the medicine of intracranial pressure in preparation.
Mannitol sodium chloride injection of the present invention has used new technique, do not add any adjuvant in the preparation of employing low temperature and ultrafiltration new technique, the preparation process, do not add active carbon, so just solve fructose instability problem (generation 5 hydroxymethyl furfural) and the residual safety issue of active carbon, eliminated clinical safety hidden danger.
Following experimental example and embodiment are used for further specifying the present invention but are not limited to the present invention
Experimental example 1
Condition: stirred 30 minutes.(5 hydroxymethyl furfural is abbreviated as 5-HMF.)
The selection of table 1 preparation temperature
| Condition | 30℃ | 40℃ | 50℃ | 60℃ | 70℃ | 80℃ | 90℃ | 100℃ |
| 5-HMF | 0.02 | 0.03 | 0.02 | 0.03 | 0.09 | 0.12 | 0.16 | 0.18 |
Table 1 result of the test shows, low temperature is conducive to the stable of fructose.
Experimental example 2
Condition: ultrafiltration test 1,2,3 adopts ultrafiltration membrance filter to carry out bacterial endotoxin evaluation and checking; Active carbon 1,2 adopts and to add behind the active carbon with carrying out bacterial endotoxin evaluation and checking behind the 0.22um filtering with microporous membrane.
Table 2 ultrafiltration and activated carbon process contrast test
| Condition | Ultrafiltration test 1 | Ultrafiltration test 2 | Ultrafiltration test 3 | Active carbon 1 | Active carbon 2 |
| Endotoxin | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification |
Table 2 result of the test shows, ultrafiltration can be removed the thermal source in the injection, and adds active carbon and can reach same effect.
The embodiment of the invention all can realize the effect of above-mentioned experimental example.
Embodiment 1
Add water for injection 540ml in preparing tank, approximately 45 ℃ of temperature add glycerol 100g, sodium chloride 9g, and stirring and dissolving is filtered into dilute preparing tank; Add aseptic injection and make dissolving with fructose 50g, add to dose volume 1000ml, measure content and up to specification, with 0.22um microporous filter membrane and ultrafiltration membrance filter, again fill, sterilization, lamp inspection, pack and get final product.
Embodiment 2
In preparing tank, add water for injection 630ml, approximately 35 ℃ of temperature, add glycerol 100g, sodium chloride 9g, stirring and dissolving adds aseptic injection and makes dissolving with fructose 50g, adds to dose volume 1000ml, measure content and up to specification, with 0.45um and 0.22um microporous filter membrane and use ultrafiltration membrance filter, again fill, sterilization, are packed and be get final product lamp inspection.
Embodiment 3
In preparing tank, add water for injection 450ml, approximately 55 ℃ of temperature, add glycerol 100g, sodium chloride 9g, stirring and dissolving adds fructose for injection 50g and makes dissolving, adds to dose volume 1000ml, measure content and up to specification, with 0.45um and 0.22um microporous filter membrane and use ultrafiltration membrance filter, again fill, sterilization, are packed and be get final product lamp inspection.
Embodiment 4
Add water for injection 540ml in preparing tank, approximately 50 ℃ of temperature add glycerol 100g, and stirring and dissolving is filtered into dilute preparing tank; Add aseptic injection and make dissolving with fructose 50g and sodium chloride 9g, add to dose volume, measure content and up to specification, with two groups of 0.22um microporous filter membrane and ultrafiltration membrance filter, again fill, sterilization, lamp inspection, pack and get final product.
Embodiment 5
Add water for injection 585ml in preparing tank, approximately 40 ℃ of temperature add glycerol 100g, and stirring and dissolving is filtered into dilute preparing tank; Add aseptic injection and make dissolving with fructose 50g and sodium chloride 9g, add to dose volume, measure content and up to specification, with 0.22um microporous filter membrane and ultrafiltration membrance filter, and again filter rear fill, sterilization with the 0.22um microporous filter membrane, lamp inspection, pack and get final product.
Embodiment 6
Add water for injection 540ml in preparing tank, approximately 45 ℃ of temperature add glycerol 20g, sodium chloride 12g, and stirring and dissolving is filtered into dilute preparing tank; Add aseptic injection and make dissolving with fructose 15g, add to dose volume 1000ml, measure content and up to specification, with 0.22um microporous filter membrane and ultrafiltration membrance filter, again fill, sterilization, lamp inspection, pack and get final product.
Embodiment 7
Add water for injection 585ml in preparing tank, approximately 40 ℃ of temperature add glycerol 165g, and stirring and dissolving is filtered into dilute preparing tank; Add aseptic injection and make dissolving with fructose 95g and sodium chloride 39g, add to dose volume, measure content and up to specification, with 0.22um microporous filter membrane and ultrafiltration membrance filter, and again filter rear fill, sterilization with the 0.22um microporous filter membrane, lamp inspection, pack and get final product.
Claims (10)
1. a Mannitol sodium chloride injection is characterized in that preparing by the following method: glycerol 50-150 weight portion, sodium chloride 5-15 weight portion, fructose for injection 10-100 weight portion are adopted low temperature preparation, ultra-filtration filters; Wherein low temperature refers to 30 ℃--60 ℃; Inject water to 1000 parts by volume.
2. a kind of Mannitol sodium chloride injection as claimed in claim 1 is characterized in that low temperature refers to 35 ℃, 40 ℃, 45 ℃, 50 ℃ or 55 ℃.
3. a kind of Mannitol sodium chloride injection as claimed in claim 1 is characterized in that ultra-filtration filters refers to 0.45um or 0.22um filtering with microporous membrane and/or ultrafiltration membrance filter.
4. a kind of Mannitol sodium chloride injection as claimed in claim 1 is characterized in that glycerol 100 weight portions, sodium chloride 9 weight portions, fructose for injection 50 weight portions; Glycerol 20 weight portions, sodium chloride 12 weight portions, fructose for injection 15 weight portions; Perhaps glycerol 165 weight portions, sodium chloride 3 weight portions, fructose for injection 95 weight portions.
5. in preparation application in the medicine of intracranial pressure is fallen such as the arbitrary described a kind of Mannitol sodium chloride injection of claim 1-4.
6. the preparation method of a Mannitol sodium chloride injection is characterized in that the method is: glycerol 50-150 weight portion, sodium chloride 5-15 weight portion, fructose for injection 10-100 weight portion are adopted low temperature preparation, ultra-filtration filters; Wherein low temperature refers to 30 ℃--60 ℃; Inject water to 1000 parts by volume.
7. the preparation method of a kind of Mannitol sodium chloride injection as claimed in claim 6 is characterized in that low temperature refers to 35 ℃, 40 ℃, 45 ℃, 50 ℃ or 55 ℃.
8. such as the preparation method of claim 6 or 7 described a kind of Mannitol sodium chloride injections, it is characterized in that ultra-filtration filters refers to 0.45um or 0.22um filtering with microporous membrane and/or ultrafiltration membrance filter.
9. such as the preparation method of claim 6 or 7 described a kind of Mannitol sodium chloride injections, it is characterized in that glycerol 100 weight portions, sodium chloride 9 weight portions, fructose for injection 50 weight portions.
10. the preparation method of a kind of Mannitol sodium chloride injection as claimed in claim 8 is characterized in that glycerol 100 weight portions, sodium chloride 9 weight portions, fructose for injection 50 weight portions.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510053310.4A CN104666340B (en) | 2011-08-03 | 2011-08-03 | A kind of Mannitol sodium chloride injection and its preparation process |
| CN201110220697XA CN102908360A (en) | 2011-08-03 | 2011-08-03 | Glycerin fructose sodium chloride injection and preparation process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110220697XA CN102908360A (en) | 2011-08-03 | 2011-08-03 | Glycerin fructose sodium chloride injection and preparation process thereof |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510053310.4A Division CN104666340B (en) | 2011-08-03 | 2011-08-03 | A kind of Mannitol sodium chloride injection and its preparation process |
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| CN102908360A true CN102908360A (en) | 2013-02-06 |
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| CN201110220697XA Pending CN102908360A (en) | 2011-08-03 | 2011-08-03 | Glycerin fructose sodium chloride injection and preparation process thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103417568A (en) * | 2013-08-08 | 2013-12-04 | 张志英 | Glycerin fructose sodium chloride injection and preparation method thereof |
| CN104922009A (en) * | 2014-03-20 | 2015-09-23 | 陈清立 | Pearl quantum magnetized liquid |
| CN105213424A (en) * | 2014-07-04 | 2016-01-06 | 成都青山利康药业有限公司 | A kind of preparation method of Mannitol sodium chloride injection |
| CN106727680A (en) * | 2016-12-27 | 2017-05-31 | 山东齐都药业有限公司 | A kind of Mannitol sodium chloride injection and preparation method |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1864693A (en) * | 2005-05-18 | 2006-11-22 | 曾列丹 | A glycerin and fructose injection and preparation method thereof |
| CN101327200A (en) * | 2008-07-30 | 2008-12-24 | 北京国仁堂医药科技发展有限公司 | Glycerol fruit sugar injection and preparation method thereof |
| CN101642430A (en) * | 2009-08-06 | 2010-02-10 | 蚌埠丰原医药科技发展有限公司 | Preparation method of glycerin and fructose injection |
| CN101836997A (en) * | 2010-05-20 | 2010-09-22 | 西安万隆制药有限责任公司 | Glycerol/fructose composite and preparation method thereof |
| CN101991589A (en) * | 2009-08-11 | 2011-03-30 | 四川科伦药物研究有限公司 | Glycerol fructose injection and preparation method thereof |
-
2011
- 2011-08-03 CN CN201110220697XA patent/CN102908360A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1864693A (en) * | 2005-05-18 | 2006-11-22 | 曾列丹 | A glycerin and fructose injection and preparation method thereof |
| CN101327200A (en) * | 2008-07-30 | 2008-12-24 | 北京国仁堂医药科技发展有限公司 | Glycerol fruit sugar injection and preparation method thereof |
| CN101642430A (en) * | 2009-08-06 | 2010-02-10 | 蚌埠丰原医药科技发展有限公司 | Preparation method of glycerin and fructose injection |
| CN101991589A (en) * | 2009-08-11 | 2011-03-30 | 四川科伦药物研究有限公司 | Glycerol fructose injection and preparation method thereof |
| CN101836997A (en) * | 2010-05-20 | 2010-09-22 | 西安万隆制药有限责任公司 | Glycerol/fructose composite and preparation method thereof |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103417568A (en) * | 2013-08-08 | 2013-12-04 | 张志英 | Glycerin fructose sodium chloride injection and preparation method thereof |
| CN104922009A (en) * | 2014-03-20 | 2015-09-23 | 陈清立 | Pearl quantum magnetized liquid |
| CN105213424A (en) * | 2014-07-04 | 2016-01-06 | 成都青山利康药业有限公司 | A kind of preparation method of Mannitol sodium chloride injection |
| CN105213424B (en) * | 2014-07-04 | 2019-01-08 | 成都青山利康药业有限公司 | A kind of preparation method of Mannitol sodium chloride injection |
| CN106727680A (en) * | 2016-12-27 | 2017-05-31 | 山东齐都药业有限公司 | A kind of Mannitol sodium chloride injection and preparation method |
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Application publication date: 20130206 |