CN102106813A - Sodium new neohouttuyfonate injection and preparation method and application thereof - Google Patents
Sodium new neohouttuyfonate injection and preparation method and application thereof Download PDFInfo
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- CN102106813A CN102106813A CN2009102564385A CN200910256438A CN102106813A CN 102106813 A CN102106813 A CN 102106813A CN 2009102564385 A CN2009102564385 A CN 2009102564385A CN 200910256438 A CN200910256438 A CN 200910256438A CN 102106813 A CN102106813 A CN 102106813A
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Abstract
The invention discloses the preparation method of sodium new neohouttuyfonate injection. The preparation comprises sodium new neohouttuyfonate, tween-80, sodium hydrosulfite and water for injection. In the invention, the sodium new neohouttuyfonate and 1-40 times the amount of tween-80 are fully ground uniformly and dissolved with the water for injection so as to ensure that the sodium new neohouttuyfonate can be fully dissolved into the water for injection and does not separate out during the preparing and filtering process; and meanwhile, the sodium hydrosulfite is added to prevent the sodium new neohouttuyfonate from being oxidized and degraded during the process flow. The sodium new neohouttuyfonate injection is used for treating various inflammations of digestive tract, pneogaster and urinary organs and can also be used for treating upper respiratory tract infection, chronic bronchitis, pulmonitis, and the like.
Description
Technical field
The present invention relates to a kind of new houttuynine sodium bisulfite injection and its production and use, belong to chemical field of medicaments.
Background technology
The new houttuynine sodium bisulfite injection Main Ingredients and Appearance is a neo-houttuyninum, and the sodium sulfite addition product of chemical name lauroyl acetaldehyde is white flakey or acicular crystal or crystalline powder, has little smelly.Easily molten in hot water, slightly soluble in water, ethanol, almost insoluble in chloroform, benzene, easily molten in the sodium hydroxide test, but decompose simultaneously.
This product is the synthetics of a kind of acids composition in the saururaceae plant houttuynia cordata Herb volatile oil.Diplococcus pneumoniae, Bacillus typhi, staphylococcus aureus, escherichia coli and sporothrix etc. there is obvious inhibitory action.But human body immunity improving power strengthens the leukocytic phagocytic function of patient, improves serum properdin level, improves the body non-specific immunity.
In the experiment white mice of 20 groups of 18～20g (5 every group), tail vein injection this product 0.3ml, or lumbar injection 1ml in 24 hours, do not see any poisoning symptom and the phenomena of mortality.
40 of Cavia porcellus experiments, 20 compare test, press 8 minutes 2 times lumbar injections of consumption per day, and successive administration was put to death after 30 days.Tissues such as the administration animal heart, liver, kidney, lung there is no specificity pathology pathological changes.
At present, be that main active ingredient is applied to the clinical new houttuynine sodium bisulfite injection that only has with neo-houttuyninum.
New houttuynine sodium bisulfite injection is mainly used in and is used for digestive tract, respiratory tract, the various inflammation of urinary system, and is used for upper respiratory tract infection, chronic bronchitis, pneumonia etc.Intramuscular injection, one time 2 times on the 81118th, one.
Because of the solubility of neo-houttuyninum, clarity and stability of formulation perplex each manufacturing enterprise all the time in the new houttuynine sodium bisulfite injection so far, have milky point or crystallization and separate out in storage process, still can use after melt and dissolved but soak in hot water.But brought inconvenience for clinical use, even can be thought by mistake medicinal liquid goes bad and the refusal use by doctor, patient.
Summary of the invention
The object of the present invention is to provide a kind of new houttuynine sodium bisulfite injection, during clinical use, preparation stabilization can not cause separating out of trace under the room temperature.
A further object of the present invention is to provide a kind of preparation method of new houttuynine sodium bisulfite injection.Of the present invention a kind of new
Houttuynine sodium bisulfite injection contains neo-houttuyninum, tween 1, sodium sulfite, water for injection in the preparation.The present invention fully grinds the tween 1 of neo-houttuyninum and 1～40 times of amount evenly, the dissolving of reuse water for injection, guaranteed that neo-houttuyninum can fully be dissolved in the water for injection, do not separate out in preparation, filtration process, add sodium sulfite simultaneously and avoid neo-houttuyninum oxidized degraded in technical process.
The preparation method of a kind of new houttuynine sodium bisulfite injection of the present invention, comprise the steps: earlier the tween one 80 of neo-houttuyninum with 1～40 times of amount to be ground evenly, other gets 1～5 times water for injection dissolving sodium sulfite, two kinds of medicinal liquids are mixed, regulate pH value, sterilize and make new houttuynine sodium bisulfite injection.
The preparation method of new houttuynine sodium bisulfite injection of the present invention specifically comprises the steps:
Elder generation is even with the tween one 80 abundant grindings of neo-houttuyninum and 1～40 times of amount, gets medicinal liquid a, and the water for injection of other taking liquid a1～5 times amount, adding sodium sulfite fully stir to make fully and dissolves, and get medicinal liquid b; With medicinal liquid a and the abundant mix homogeneously of medicinal liquid b, add 0,01%～0,5% active carbon, heated and boiled 15～30 minutes, decarbonization filtering, last adjust pH is 4,5～6,5, fill behind end-filtration, sterilization, lamp inspection, packing form injection.
The pH of new houttuynine sodium bisulfite injection of the present invention is 4.5～6.5, is preferably pH5.0～5.5, and the pH value regulator can be selected this area regulator commonly used for use, such as 10% sodium hydroxide or 10% hydrochloric acid solution.
Sterilizing installation and technology that described sterilization can adopt those skilled in the art to use always.For example, use water-bath sterilization or steam sterilization, sterilized 30-45 minute down at 100-110 ℃.
Preferably, the preparation method of new houttuynine sodium bisulfite injection of the present invention, comprise the steps: that the tween of earlier neo-houttuyninum being received with 1～40 times of amount 1 fully grinds evenly, get medicinal liquid a, the water for injection of other taking liquid a1～5 times amount, the adding sodium sulfite fully stirs and makes dissolving fully, gets medicinal liquid b; With medicinal liquid a and the abundant mix homogeneously of medicinal liquid b, add 0.01～0,5% active carbon, heated and boiled 15～30 minutes, decarbonization filtering, last adjust pH is 4.5～6.5, fill behind end-filtration, sterilization, lamp inspection, packing form injection.
The new houttuynine sodium bisulfite injection that adopts preparation method of the present invention and get, character is colourless or flaxen clear liquid, specification can be 1ml, 2ml, 4ml, 5ml, 10ml, 15ml, and most preferred specification is 2ml, 5ml, 10ml, and every ml contains neo-houttuyninum 2mg8.
New houttuynine sodium bisulfite injection is mainly used in and is used for digestive tract, respiratory tract, the various inflammation of urinary system, and is used for upper respiratory tract infection, chronic bronchitis, pneumonia etc.Intramuscular injection, a 8mg, 2 times on the one.
This product is the synthetics of a kind of aldehydes composition in the saururaceae plant houttuynia cordata Herb volatile oil.Diplococcus pneumoniae, Bacillus typhi, staphylococcus aureus, escherichia coli and sporothrix etc. there is obvious inhibitory action.But human body immunity improving power strengthens the leukocytic phagocytic function of patient, improves serum properdin level, improves the body non-specific immunity.
In 20 group 18～208 experiment white mice (5 every group), tail vein injection this product 0.3ml, or lumbar injection 1ml in 24 hours, do not see any poisoning symptom and the phenomena of mortality.
40 of Cavia porcellus experiments, 20 compare test, press consumption per day 8mg/kg, divide 2 times lumbar injection, and successive administration was put to death after 30 days.Tissues such as the administration animal heart, liver, kidney, lung there is no specificity pathology pathological changes.
The specific embodiment
Following embodiment further describes the present invention, but described embodiment only is used to illustrate the present invention rather than restriction the present invention.
Embodiment 1
Earlier the tween 1 with neo-houttuyninum and 10 times of amounts fully grinds evenly, medicinal liquid a, the water for injection doubly measured of taking liquid a1 in addition adds 0.05% sodium sulfite and fully stirs and make dissolving fully, gets medicinal liquid b; With medicinal liquid a and the abundant mix homogeneously of medicinal liquid b, add 0.03% active carbon, heated and boiled 30 minutes, decarbonization filtering, last adjust pH is 4.5, fill behind end-filtration, sterilization, lamp inspection, packing form injection.
Embodiment 2
Earlier the tween 1 with neo-houttuyninum and 20 times of amounts fully grinds evenly, medicinal liquid a, the water for injection doubly measured of taking liquid a3 in addition adds 0.08% sodium sulfite and fully stirs and make dissolving fully, gets medicinal liquid b; With medicinal liquid a and the abundant mix homogeneously of medicinal liquid b, add 0.1% active carbon, heated and boiled 20 minutes, decarbonization filtering, last adjust pH is 5.0, fill behind end-filtration, sterilization, lamp inspection, packing form injection.
Embodiment 3
Earlier the tween 1 with neo-houttuyninum and 1 times of amount fully grinds evenly, medicinal liquid a, the water for injection doubly measured of taking liquid a5 in addition adds 1.0% sodium sulfite and fully stirs and make dissolving fully, gets medicinal liquid b; With medicinal liquid a and the abundant mix homogeneously of medicinal liquid b, add 0.4% active carbon, heated and boiled 20 minutes, decarbonization filtering, last adjust pH is 6.0, fill behind end-filtration, sterilization, lamp inspection, packing form injection.
Embodiment 4
Earlier the tween 1 with neo-houttuyninum and 40 times of amounts fully grinds evenly, medicinal liquid a, the water for injection doubly measured of taking liquid a3 in addition adds 0.05% sodium sulfite and fully stirs and make dissolving fully, gets medicinal liquid b; With medicinal liquid a and the abundant mix homogeneously of medicinal liquid b, add 0.5% active carbon, heated and boiled 15 minutes, decarbonization filtering, last adjust pH is 5.5, fill behind end-filtration, sterilization, lamp inspection, packing form injection.
Embodiment 5
Earlier the tween 1 with neo-houttuyninum and 30 times of amounts fully grinds evenly, medicinal liquid a, the water for injection doubly measured of taking liquid a4 in addition adds 0.07% sodium sulfite and fully stirs and make dissolving fully, gets medicinal liquid b; With medicinal liquid a and the abundant mix homogeneously of medicinal liquid b, add 0.2% active carbon, heated and boiled 20 minutes, decarbonization filtering, last adjust pH is 6.0, fill behind end-filtration, sterilization, lamp inspection, packing form injection.
Claims (6)
1. a new houttuynine sodium bisulfite injection comprises neo-houttuyninum, tween 1, sodium sulfite, water for injection; It is characterized in that the tween 1 that neo-houttuyninum and 1-40 are doubly measured fully grinds evenly, the dissolving of reuse water for injection, guaranteed that neo-houttuyninum can fully be dissolved in the water for injection, do not separate out in preparation, filtration process, add sodium sulfite simultaneously and avoid neo-houttuyninum oxidized degraded in technical process.
2. a kind of new houttuynine sodium bisulfite injection according to claim 1 is characterized in that, described sodium sulfite consumption is the 0.05-1.0% of total dose volume.
3. the employed tween 1 of new houttuynine sodium bisulfite injection according to claim 1 is commercially available medicinal specification.
4. according to any one new houttuynine sodium bisulfite injection in claim 1 or 2, it is characterized in that described filtration filter membrane is the filter membrane of general material.
5. the preparation method of new houttuynine sodium bisulfite injection according to claim 1, it is characterized in that, comprise the steps: earlier the tween 80 that neo-houttuyninum and 1-40 doubly measure is fully ground evenly, get medicinal liquid a, taking liquid is converted the water for injection of 5 times of amounts in addition, the adding sodium sulfite fully stirs and makes dissolving fully, gets medicinal liquid b; With medicinal liquid a and the abundant mix homogeneously of medicinal liquid b, add the active carbon of 0.01-0.5%, heated and boiled 15-30 minute, decarbonization filtering, last adjust pH is 4.5-6.5, fill behind end-filtration, sterilization, lamp inspection, packing form injection.
6. new houttuynine sodium bisulfite injection according to claim 1 is used for digestive tract, respiratory tract, the various inflammation of urinary system, and is used for upper respiratory tract infection, chronic bronchitis, pneumonia etc.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009102564385A CN102106813A (en) | 2009-12-25 | 2009-12-25 | Sodium new neohouttuyfonate injection and preparation method and application thereof |
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| CN2009102564385A CN102106813A (en) | 2009-12-25 | 2009-12-25 | Sodium new neohouttuyfonate injection and preparation method and application thereof |
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| CN102106813A true CN102106813A (en) | 2011-06-29 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102872105A (en) * | 2012-10-27 | 2013-01-16 | 南京大学 | Application of Houttuynoid C in antibacterial medicine |
| CN103265459A (en) * | 2013-06-03 | 2013-08-28 | 四川省惠达药业有限公司 | Novel sodium houttuyfonate compound as well as preparation method and pharmaceutical composition thereof |
-
2009
- 2009-12-25 CN CN2009102564385A patent/CN102106813A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102872105A (en) * | 2012-10-27 | 2013-01-16 | 南京大学 | Application of Houttuynoid C in antibacterial medicine |
| CN102872105B (en) * | 2012-10-27 | 2013-10-23 | 南京大学 | Application of Houttuynoid C in antibacterial medicine |
| CN103265459A (en) * | 2013-06-03 | 2013-08-28 | 四川省惠达药业有限公司 | Novel sodium houttuyfonate compound as well as preparation method and pharmaceutical composition thereof |
| CN103265459B (en) * | 2013-06-03 | 2015-09-09 | 四川省惠达药业有限公司 | A kind of novel sodium houttuyfonate compound, its preparation method and pharmaceutical composition thereof |
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Application publication date: 20110629 |