CN1568956A - Compound diisopropylamine dichloroacetate powder and injection prreparations - Google Patents
Compound diisopropylamine dichloroacetate powder and injection prreparations Download PDFInfo
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- CN1568956A CN1568956A CN 200410024056 CN200410024056A CN1568956A CN 1568956 A CN1568956 A CN 1568956A CN 200410024056 CN200410024056 CN 200410024056 CN 200410024056 A CN200410024056 A CN 200410024056A CN 1568956 A CN1568956 A CN 1568956A
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- diisopropylamine dichloroacetate
- compound
- powder
- injectable powder
- injection
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Abstract
The invention discloses a compound diisopropylamine dichloroacetate powder and injection preparations, which is prepared from the following components (by weight percent) disopropylamine dchloroacetate 0.125-51.29%, sodium gluconate 0.125-48.71%, excipient 0-99.75%.
Description
(1) technical field
The present invention relates to a kind of compound diisopropylamine dichloroacetate injectable powder, belong to medical technical field.
(2) background technology
The hepatitis disease infects widely, and morbidity is high, and all kinds of hepatopaths of China are existing more than 1.2 hundred million according to statistics, and such patient is all arranged in everyone life range.Along with growth in the living standard, dietary structure and life style all have bigger change, and some " modern diseasies ", " affluenza " sickness rate are more and more higher, and fatty liver is exactly wherein most typical a kind of.Shenzhen's pathogenesis of fatty liver rate rises gradually, and fatty liver has become the second largest hepatopathy that threatens citizen's health, is only second to viral hepatitis.Professor Ye Hongjun points out, in Shenzhen, surpasses 10% people and suffers from this disease, Shenzhen one tame hospital year health check-up fatty liver recall rate even up to 39%.Significant is especially, and owing to increasing of Obese children, pathogenesis of fatty liver is the trend of becoming younger, and Shenzhen hospital of Beijing University just once accepted the little patient that a fatty liver when only 14 changes liver cirrhosis for medical treatment.Therefore, all kinds of hepatopathys of active treatment are more and more paid attention to by people.
Compound diisopropylamine dichloroacetate is the compound preparation that diisopropylamine dichloroacetate and gluconic acid sodium salt are formed, and is the active component of vitamin (dimension heparin), and 4 methyl are arranged on its chemical constitution, can be for the synthetic required methyl of choline of body.Choline participates in lipid metabolism in vivo, and choline is the ingredient of phospholipid, and lecithin can constitute lipoprotein and be easy to be dissolved in blood plasma with fat, cholesterol and protein, and it is outer to reduce the fat of intrahepatic deposition that intrahepatic fat is transported to liver with the formation of lipoprotein.Life-time service confirms both at home and abroad: this medicine can obviously improve acute and chronic hepatitis, also can be used for fatty liver and other all liver malfunctions.The preparation of compound diisopropylamine dichloroacetate listing at present is tablet and injection, yet the compound diisopropylamine dichloroacetate injection need easily cause decomposition behind high temperature sterilize in preparation process, and product quality is descended.
(3) summary of the invention
The present invention has avoided the deficiency of above-mentioned technology, and a kind of compound diisopropylamine dichloroacetate injectable powder is provided.
The present invention is a kind of compound diisopropylamine dichloroacetate injectable powder, comprises following component, all is weight percentage: diisopropylamine dichloroacetate 0.125%~51.29%, gluconic acid sodium salt 0.125%~48.71%, excipient are 0~99.75%.
Above-mentioned excipient is selected from one or more in mannitol, lactose, glycine, sorbitol, low molecular dextran, glucose, sucrose, hydrolysis gel, cyclodextrin, the cyclodextrin derivative.Molecular weight gets final product by this area normal ranges.
Above-mentioned compound diisopropylamine dichloroacetate injectable powder can be a kind of in sterilized powder, the aseptic freeze-dried product.
Compared with prior art, excellent results of the present invention is as follows:
1) this product has been selected injectable powder, and whole preparation process all is to carry out mild condition under the condition of low temperature or room temperature, no high temperature sterilize, avoided injection to adopt high temperature sterilize easily to cause compound diisopropylamine dichloroacetate to decompose, reduced the phenomenon of product quality, made clinical practice safer.
2) the compound diisopropylamine dichloroacetate injectable powder has the quick-dissolving characteristics of the water of chance, for clinical use provides convenience.
The compound diisopropylamine dichloroacetate injectable powder that is made by said method all complies with relevant regulations in the check of items such as content, aseptic, pH, has no side effect.This product can be used for intramuscular injection or intravenous drip, is used for the treatment of acute and chronic hepatitis, also can be used for fatty liver and other all liver malfunctions.
(4) specific embodiment
Embodiment 1 compound diisopropylamine dichloroacetate injectable powder, component is as follows, all is weight percentage:
Diisopropylamine dichloroacetate 6.93%
Gluconic acid sodium salt 6.57%
Mannitol 86.50%
Preparation method is as follows:
Get diisopropylamine dichloroacetate raw material 20g, gluconic acid sodium salt 19g adds water for injection 1.5L, and stirring and dissolving with mannitol 250g stirring and dissolving, is added water for injection to 2L, add pin with charcoal after stirring at room, filtering decarbonization, fine straining.Filtrate is carried out packing by every 2ml, promptly obtains the aseptic freeze-dried product of compound diisopropylamine dichloroacetate through lyophilization.
Embodiment 2 compound diisopropylamine dichloroacetate injectable powder, component is as follows, all is weight percentage:
Diisopropylamine dichloroacetate 51.29%
Gluconic acid sodium salt 48.71%
Preparation method is with 1.
Embodiment 3 compound diisopropylamine dichloroacetate injectable powder, component is as follows, all is weight percentage:
Diisopropylamine dichloroacetate 14.39%
Gluconic acid sodium salt 13.67%
Lactose 71.94%
Preparation method is as follows:
Get diisopropylamine dichloroacetate raw material 40g, gluconic acid sodium salt 38g adds water for injection 3.0L, and stirring and dissolving adds lactose 200g stirring and dissolving, adds water for injection to 4L, add pin with charcoal after stirring at room, filtering decarbonization, fine straining.Filtrate is at the spray-dried compound diisopropylamine dichloroacetate sterilized powder that promptly gets.Undertaken aseptic subpackagedly then by every 40mg (in diisopropylamine dichloroacetate), promptly get compound diisopropylamine dichloroacetate powder pin.
Embodiment 4 compound diisopropylamine dichloroacetate injectable powder, component is as follows, all is weight percentage:
Diisopropylamine dichloroacetate 1.961%
Gluconic acid sodium salt 1.862%
Glucose 96.177%
Preparation method is with 3.
Embodiment 5 compound diisopropylamine dichloroacetate injectable powder, component is as follows, all is weight percentage:
Diisopropylamine dichloroacetate 31.25%
Gluconic acid sodium salt 29.69%
Sorbitol 39.06%
Preparation method is as follows:
Get dichloroacetic acid 2-aminopropane. 80g, gluconic acid sodium salt 76g adds water for injection 1.5L, and stirring and dissolving adds sorbitol 100g stirring and dissolving, adds water for injection to 2L, add pin with charcoal after stirring at room, filtering decarbonization, fine straining.Filtrate promptly gets the compound diisopropylamine dichloroacetate sterilized powder through vacuum drying.Undertaken aseptic subpackagedly then by every 80mg (in diisopropylamine dichloroacetate), promptly get compound diisopropylamine dichloroacetate powder pin.
Embodiment 6 compound diisopropylamine dichloroacetate injectable powder, component is as follows, all is weight percentage:
Diisopropylamine dichloroacetate 0.500%
Gluconic acid sodium salt 0.495
Glucose 99.005%
Preparation method is with 5.
Claims (3)
1, the present invention is a kind of compound diisopropylamine dichloroacetate injectable powder, it is characterized in that, comprise following component, all be weight percentage: diisopropylamine dichloroacetate 0.125%~51.29%, gluconic acid sodium salt 0.125%~48.71%, excipient are 0~99.75%.
2, a kind of compound diisopropylamine dichloroacetate injectable powder as claimed in claim 1, it is characterized in that described excipient is one or more in mannitol, lactose, glycine, sorbitol, low molecular dextran, glucose, sucrose, hydrolysis gel, cyclodextrin, the cyclodextrin derivative.
3, a kind of compound diisopropylamine dichloroacetate injectable powder as claimed in claim 1 is characterized in that, described compound diisopropylamine dichloroacetate injectable powder can be a kind of in sterilized powder, the aseptic freeze-dried product.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN 200410024056 CN1568956A (en) | 2004-04-28 | 2004-04-28 | Compound diisopropylamine dichloroacetate powder and injection prreparations |
Applications Claiming Priority (1)
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CN 200410024056 CN1568956A (en) | 2004-04-28 | 2004-04-28 | Compound diisopropylamine dichloroacetate powder and injection prreparations |
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CN1568956A true CN1568956A (en) | 2005-01-26 |
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CN 200410024056 Pending CN1568956A (en) | 2004-04-28 | 2004-04-28 | Compound diisopropylamine dichloroacetate powder and injection prreparations |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103304424A (en) * | 2013-07-02 | 2013-09-18 | 湖北美林药业有限公司 | Diisopropylamine dichloroacetate compound and compound medicine composition injection thereof |
CN107213120A (en) * | 2017-06-09 | 2017-09-29 | 安徽赛诺制药有限公司 | A kind of Diisopropylamine Dichloroacetate freeze-dried powder and preparation method thereof |
-
2004
- 2004-04-28 CN CN 200410024056 patent/CN1568956A/en active Pending
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103304424A (en) * | 2013-07-02 | 2013-09-18 | 湖北美林药业有限公司 | Diisopropylamine dichloroacetate compound and compound medicine composition injection thereof |
CN107213120A (en) * | 2017-06-09 | 2017-09-29 | 安徽赛诺制药有限公司 | A kind of Diisopropylamine Dichloroacetate freeze-dried powder and preparation method thereof |
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Addressee: Xiao Guangchang Document name: Notice of publication of application for patent for invention |
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WD01 | Invention patent application deemed withdrawn after publication |