CN102440949A - Preparation method of fructose injection - Google Patents
Preparation method of fructose injection Download PDFInfo
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- CN102440949A CN102440949A CN2010105004405A CN201010500440A CN102440949A CN 102440949 A CN102440949 A CN 102440949A CN 2010105004405 A CN2010105004405 A CN 2010105004405A CN 201010500440 A CN201010500440 A CN 201010500440A CN 102440949 A CN102440949 A CN 102440949A
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- fructose
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Abstract
The invention discloses a preparation method of a fructose injection. The method comprises steps of: taking fructose, adding injection water, dissolving, realizing a constant volume, adding concentrated hydrochloric acid to adjust a pH value to 3.2-3.5, adding active carbon, stirring, decarburizing, carrying out refined filtration, filling, arranging plug, capping, disinfecting, carrying out lamp inspection and packaging. According to the invention, the pH value is adjusted to 3.2-3.5, so that generation of relevant substance 5-hydroxymethylfurfural in the preparation is reduced substantially.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of fructose injection with its preparation method.
Background technology
Fructose injection is a kind of energy and body fluid supplement. fructose more is prone to form glycogen than glucose, mainly passes through the fructokinase metabolism at liver, and being easy to metabolism is fruit acid, is converted into energy rapidly.(1), need to be used to the patient of makeup energy and body fluid.(2), be used for the low anti-sugared disease patient that causes because of postoperative, burn, wound and bacteremia etc.(3), the energy and the body fluid that are used for diabetics replenish.(4), being used to treat acute ethanol poisons.
Fructose in the preparation through dosing, remove thermal source, decarburization, fine straining, top plug, roll lid, can generation related substance 5-hydroxyl furfural after the sterilization; This material injects the people and knows from experience the generation severe anaphylactic reaction; Therefore, it is very important to reduce the generation of 5-hydroxyl furfural in process of production.
At present, the fructose injection 5-hydroxyl furfural content of domestic production is higher, should be noted that the generation toxic and side effects during use.
Summary of the invention
The objective of the invention is on the basis of existing technology, a kind of method for preparing of fructose injection is provided.
Specifically; The inventor reaches and improves the fructose injection quality through regulating PH to a specific scope of fructose injection, reduces the purpose that related substance 5-hydroxyl furfural produces; Wherein the PH of fructose injection is adjusted to 3～4, and preferred acid basicity is adjusted to 3.2～3.5.
The method for preparing of fructose injection of the present invention, concrete steps are: get fructose, add the dissolving of injection water, standardize solution, add concentrated hydrochloric acid and regulate pH value to 3.2～3.5, add active carbon, stir, take off charcoal, fine straining, fill, top plug rolls lid, sterilization, lamp inspection, packing.
Wherein preferably regulate pH value to 3.3～3.4.The mass content of fructose is preferably 2.5%～15/% in the fructose injection; Further be preferably 4～11%.
Invent said microporous filter membrane aperture for being 0.22 μ m.
Invent described fructose and can adopt the raw material that meets medicinal standard.
The inventor studies fructose injection, the unexpected discovery, in above-mentioned invention, PH is adjusted to 3.2～3.5 after, the generation meeting of the related substance 5-hydroxyl furfural of preparation reduces to a great extent.
The specific embodiment
Further describe the present invention with some instances below, help better understanding advantage of the present invention, effect.But used instance is to be used for explanation rather than restriction the present invention.
Embodiment 1
Prescription:
| Fructose 250g | Active carbon 5g | Water for injection 5000L |
Method for making: get the fructose of formula ratio, add the dissolving of 2500ml injection drinking water, using the pH value of hydrochloric acid solution regulator solution is 3.3 ± 0.1; Add active carbon, stir 10min, take off charcoal; Add water for injection 2500ml; With 0.22 μ m filtering with microporous membrane degerming, and make the solution clarification, the content of fructose in the inspection medicinal liquid.Filtration, sterilization, fill promptly get in the infusion bottle of 250ml.
Embodiment 2
Prescription:
| Fructose 500g | Active carbon 5g | Water for injection 5000L |
Method for making: get the fructose of formula ratio, add the dissolving of 2500ml injection drinking water, using the pH value of hydrochloric acid solution regulator solution is 3.3 ± 0.1; Add active carbon, stir 10min, take off charcoal; Add water for injection 2500ml; With 0.22 μ m filtering with microporous membrane degerming, and make the solution clarification, the content of fructose in the inspection medicinal liquid.Filtration, sterilization, fill promptly get in the infusion bottle of 250ml.
Embodiment 3
Prescription:
| Fructose 500g | Active carbon 5g | Water for injection 5000L |
Method for making: get the fructose of formula ratio, add the dissolving of 2500ml injection drinking water, using the pH value of hydrochloric acid solution regulator solution is 3.4 ± 0.1; Add active carbon, stir 10min, take off charcoal; Add water for injection 2500ml; With 0.22 μ m filtering with microporous membrane degerming, and make the solution clarification, the content of fructose in the inspection medicinal liquid.Filtration, sterilization, fill promptly get in the infusion bottle of 500ml.
Reference examples 1
Prescription:
| Fructose 250g | Active carbon 5g | Water for injection 5000L |
Method for making: get the fructose of formula ratio, add the dissolving of 2500ml injection drinking water, using the pH value of hydrochloric acid solution regulator solution is 3.0 ± 0.1; Add active carbon, stir 10min, take off charcoal; Add water for injection 2500ml; With 0.22 μ m filtering with microporous membrane degerming, and make the solution clarification, the content of fructose in the inspection medicinal liquid.Filtration, sterilization, fill promptly get in the infusion bottle of 250ml.
Reference examples 2
Prescription:
| Fructose 500g | Active carbon 5g | Water for injection 5000L |
Method for making: get the fructose of formula ratio, add the dissolving of 2500ml injection drinking water, using the pH value of hydrochloric acid solution regulator solution is 4 ± 0.1; Add active carbon, stir 10min, take off charcoal; Add water for injection 2500ml; With 0.22 μ m filtering with microporous membrane degerming, and make the solution clarification, the content of fructose in the inspection medicinal liquid.Filtration, sterilization, fill promptly get in the infusion bottle of 250ml.
Reference examples 3
Prescription:
| Fructose 500g | Active carbon 5g | Water for injection 5000L |
Method for making: get the fructose of formula ratio, add the dissolving of 2500ml injection drinking water, using the pH value of hydrochloric acid solution regulator solution is 4.5 ± 0.1; Add active carbon, stir 10min, take off charcoal; Add water for injection 2500ml; With 0.22 μ m filtering with microporous membrane degerming, and make the solution clarification, the content of fructose in the inspection medicinal liquid.Filtration, sterilization, fill promptly get in the infusion bottle of 500ml.
Experimental example
1. test method: the sample of getting each embodiment 1-3 and reference examples 1-3 places 40 calorstat to place 6 months, respectively at the content of related substance 5-hydroxyl furfural in 0 month, March, June sampling and measuring sample.
2. assay method: precision is measured these article an amount of (being equivalent to fructose 1.0g approximately), puts in the 100ml measuring bottle, and thin up shakes up to scale, according to ultraviolet-visible spectrophotometer (appendix A), measures absorbance in the 284nm wavelength.The big more explanation of absorption value 5-hydroxyl furfural content is high more.
3. mensuration result: each embodiment and reference examples 5-hydroxyl furfural content see the following form:
| ? | 0 month (absorbance) | March (absorbance) | June (absorbance) |
| Embodiment 1 | 0.09 | 0.13 | 0.17 |
| Embodiment 2 | 0.08 | 0.14 | 0.19 |
| Embodiment 3 | 0.09 | 0.12 | 0.18 |
| Reference examples 1 | 0.14 | 0.24 | 0.32 |
| Reference examples 2 | 0.13 | 0.25 | 0.33 |
| Reference examples 3 | 0.15 | 0.23 | 0.35 |
The embodiments of the invention injection obviously lacks than the 5-hydroxyl furfural that the reference examples injection contains, and in the June accelerated test, recruitment is also less, can indirect reaction injection untoward reaction of the present invention will be less.
Claims (4)
1. the method for preparing of a fructose injection is characterized in that getting fructose, adds the dissolving of injection water, standardize solution, adds concentrated hydrochloric acid and regulates pH value to 3.2～3.5, adds active carbon, stirs, and takes off charcoal, fine straining, and fill, top plug rolls lid, sterilization, lamp inspection, packing.
2. the method for preparing of fructose injection according to claim 1 is characterized in that: regulate pH value to 3.3～3.4.
3. the method for preparing of fructose injection according to claim 1, it is characterized in that: the mass content of fructose is 2.5%～15/% in the fructose injection.
4. the method for preparing of fructose injection according to claim 3, it is characterized in that: the mass content of fructose is 4～11%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010500440 CN102440949B (en) | 2010-10-09 | 2010-10-09 | Preparation method of fructose injection |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201010500440 CN102440949B (en) | 2010-10-09 | 2010-10-09 | Preparation method of fructose injection |
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| CN102440949A true CN102440949A (en) | 2012-05-09 |
| CN102440949B CN102440949B (en) | 2013-06-05 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 201010500440 Active CN102440949B (en) | 2010-10-09 | 2010-10-09 | Preparation method of fructose injection |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103385883A (en) * | 2013-08-02 | 2013-11-13 | 海南灵康制药有限公司 | Pharmaceutical composition containing tropisetron hydrochloride and fructose |
| CN108938723A (en) * | 2018-08-03 | 2018-12-07 | 张蕊 | A kind of injection and preparation method thereof containing fructose |
Citations (4)
| 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 |
| CN101721360A (en) * | 2009-11-25 | 2010-06-09 | 蚌埠丰原医药科技发展有限公司 | Urapidil 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 |
-
2010
- 2010-10-09 CN CN 201010500440 patent/CN102440949B/en active Active
Patent Citations (4)
| 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 |
| CN101721360A (en) * | 2009-11-25 | 2010-06-09 | 蚌埠丰原医药科技发展有限公司 | Urapidil 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 (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103385883A (en) * | 2013-08-02 | 2013-11-13 | 海南灵康制药有限公司 | Pharmaceutical composition containing tropisetron hydrochloride and fructose |
| CN103385883B (en) * | 2013-08-02 | 2015-05-27 | 海南灵康制药有限公司 | Pharmaceutical composition containing tropisetron hydrochloride and fructose |
| CN108938723A (en) * | 2018-08-03 | 2018-12-07 | 张蕊 | A kind of injection and preparation method thereof containing fructose |
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| Publication number | Publication date |
|---|---|
| CN102440949B (en) | 2013-06-05 |
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