CN1640390A - Novel sodium houttuynin lyophilized powder for injection and its preparing method - Google Patents
Novel sodium houttuynin lyophilized powder for injection and its preparing method Download PDFInfo
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- CN1640390A CN1640390A CN 200410000862 CN200410000862A CN1640390A CN 1640390 A CN1640390 A CN 1640390A CN 200410000862 CN200410000862 CN 200410000862 CN 200410000862 A CN200410000862 A CN 200410000862A CN 1640390 A CN1640390 A CN 1640390A
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Abstract
The present invention relates to a freeze-dried composition of new houttuynin sodium. It includes new houttuynin sodium with therapeutic effective dose and additive agent which can be freeze-dried, in which the dose of new houttuynin sodium is 0.05-0.5% of prescription solution dose, and the additive agent which can be freeze-dried includes tween-80 and dilutent agent, in which the dose of tween-80 is 0.5-2.5 % of prescription solution dose, and the dilutent agent is one kind selected from mannitol, lactose, dextran, dextrose, amino acetic acid, hydrolysed gelatin and polyvidone, etc. or mixture of them. Said invention also provides its preparation process and concrete steps.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation, specifically is neo-houttuyninum sodium freeze-dried powder injection and preparation method.
Background technology
Lauroyl acetaldehyde sodium sulfite addition product is called neo-houttuyninum, is artificial composite.Pharmacological action is similar with houttuynine sodium bisulfite (the sodium sulfite addition product of decanoylacetaldehyde), and is the strongest to staphylococcus aureus and penicillin resistant strain, streptococcus pneumoniae, alpha streptococcus and the effect of hemophilus influenza vitro inhibition; Micrococcus catarrhalis, Bacillus typhi, escherichia coli and tubercule bacillus etc. also there is certain inhibitory action.In addition, it is effective to the various skin pathogenic fungus.The clinical gynecological inflammations such as pelvic inflammatory disease, adnexitis, chronic cervicitis that are used for.
The ejection preparation of the neo-houttuyninum of listing listing at present has only dosage form of injection, and the poor stability of injection is thermo-labile, easily freezes, and stores and transport all inconvenient.Therefore we develop with the lyophilized injectable powder of polyoxyethylene sorbitan monoleate (Tween 80) as the neo-houttuyninum of solubilizing agent, have solved the defective that new houttuynine sodium bisulfite injection exists.Chinese patent CN1459284 and CN1449834 are the freeze-dried powder dosage forms of neo-houttuyninum, the both adopts the beta-schardinger dextrin-or derivatives thereof as cosolvent, at present, because the problems such as toxicity of cyclodextrin and derivant thereof are not also ratified as the adjuvant of injection at home, and as the adjuvant of injection very long history has been arranged with Tween 80, simple with Tween 80 simultaneously to the technology that medicament solubilization prepares injection, and with the complex process of cyclodextrin inclusion compound medication preparation injection, cost height.Chinese patent CN1404825 discloses a kind of preparation method of intravenous fluid of neo-houttuyninum, adopt Tween 80 as solubilizing agent, but because neo-houttuyninum is water insoluble, and Tween 80 viscosity is bigger, and those skilled in the art can't infer from general knowledge according to CN1404825 and can adopt Tween 80 neo-houttuyninum to be made that quality is loose, good appearance can dissolved again rapidly lyophilized injectable powder as solubilizing agent.
Summary of the invention
The purpose of this invention is to provide a kind of neo-houttuyninum sodium freeze-dried powder injection.Compare with new houttuynine sodium bisulfite injection, have the following advantages: 1, neo-houttuyninum is difficult for molten in water, new houttuynine sodium bisulfite injection may be separated out milky point or crystallization (seeing operation instructions) when low temperature, just avoided neo-houttuyninum owing to being difficult for the bad problem of the molten physical stability that causes after making lyophilized injectable powder.2, can avoid neo-houttuyninum in preparation process, to decompose rotten because of hyperpyrexia.3, the product quality of gained is loose, and adding behind the water rapidly, dissolving recovers the original characteristic of medicinal liquid.4, water content is low, and simultaneously drying is carried out in a vacuum, so be difficult for oxidation, good stability helps the long term store of product.5, opportunities for contamination reduces relatively in the production process, so the particle matter in the product lacks than additive method.
The present invention adds water by neo-houttuyninum, solubilizing agent and diluent and makes obtained by freeze drying behind the solution.Wherein the consumption of neo-houttuyninum is 0.05～0.5% of the prescription solution amount, and the amount that each unit formulation contains neo-houttuyninum is 1～100mg, preferred 4～20mg.Solubilizing agent is a Tween 80, and consumption is 0.5%～2.5%, preferred 1%～2% of the prescription solution amount.Described diluent is selected from mannitol, lactose, dextran, glucose, glycine, gelatin hydrolysate, polyvidone etc., preferred manna alcohol and glucose mixed diluent, mannitol: the mixed proportion of glucose is 1～8: 1, preferred 4～6: 1, and more preferably 5: 1.The consumption of diluent accounts for 2%～15% of prescription solution amount.Preferred 4%～8%.May when lyophilizing, form fine and close shell mechanism owing to contain the Tween 80 of toughness among the present invention, the water vapour of distillation penetrates difficulty, the overlong time that causes steam to stagnate at dried layer, make part principal agent and adjuvant deliquescence gradually, so that volume contraction, profile is not full or become granule, and dissolving is difficult again.Through the wonderful discovery of our deep researchs, when using mannitol as diluent separately, dissolved again speed is very slow, and after adding an amount of glucose, dissolved again speed is very fast, more convenient clinical use.Adopting repeatedly in addition, the freezing and sublimation method also can address this problem, this is because adopt repeatedly the dried shell distillation of freezing and sublimation method part vapor transmission when distillation, and a part of steam that is trapped in dried layer is frozen into solid-state again, make its principal agent and adjuvant around can't deliquescence, the dried shell distillation of some vapor transmission again when heating up once more, and that the steam that is detained then is frozen into is solid-state, so repeatedly, but adopts the used sublimation drying time of this method longer.Freeze-dry process of the present invention both can adopt a sublimed method also can adopt freezing and sublimation method repeatedly, depend primarily on the kind and the consumption of adjuvant, for example under the consumption condition with higher of Tween 80 as the prescription solution amount 1.5% adopt that the freeze dried effect of freezing and sublimation method is better repeatedly when above, when using independent a kind of diluent such as mannitol or the consumption of diluent also should use freezing and sublimation method repeatedly after a little while, use the manna alcohol and glucose to mix and then needn't adopt freezing and sublimation method repeatedly when the aforesaid proper ratio as diluent, because this method time is long, power consumption is big.
Preparation technology is: with neo-houttuyninum and polyoxyethylene sorbitan monoleate mix homogeneously, diluent is dissolved into boil in 90% the water for injection after, join stirring and dissolving in the mixed liquor of aforesaid neo-houttuyninum and Tween 80, add to the full amount of water for injection after placing room temperature, add active carbon, absorption, decarbonization filtering; Gained filtrate is continued with 0.22 μ m filtering with microporous membrane, packing, lyophilization.
The vacuum lyophilization condition:
1) pre-freeze: the medicine that branch is installed is put into and is carried out pre-freeze on the freeze drying box internal partition, and products temperature drops to-45 ℃, keeps promptly can carrying out sublimation drying after 2 hours.
2) sublimation drying:
A sublimed method: the vacuum in the drying baker reaches 13.33Pa (0.1mmHg) when following, closes fridge, slowly heats by the heating system under the dividing plate, and temperature is controlled at below-20 ℃, and the sublimation drying time is 15 hours.
Freezing and sublimation method repeatedly: the vacuum in the drying baker reaches 13.33Pa (0.1mmHg) when following, close fridge, slowly heat by the heating system under the dividing plate, when temperature rises to-20 ℃, open fridge, temperature is descended, when reducing to-45 ℃, temperature closes fridge, slowly heat by the heating system under the dividing plate, so repeatedly, the sublimation drying time is 35 hours.
3) dry again: the drying stage temperature is controlled at 20 ℃ again, and be 12 hours drying time again.
The products appearance that the present invention makes is plentiful, fine and smooth, and quality is loose, and dissolution velocity is fast again, is convenient to clinical use.
Following examples are used for further specifying the present invention, rather than limitation of the scope of the invention.
Embodiment 1
Prescription: neo-houttuyninum 4g
Tween 80 20g
Mannitol 100g
Glucose 20g
Water for injection adds to 2000ml
Make 1000 altogether
Method for making: with neo-houttuyninum and polyoxyethylene sorbitan monoleate mix homogeneously, the manna alcohol and glucose is dissolved into boil in the water for injection of 1800ml after, join stirring and dissolving in the mixed liquor of aforesaid neo-houttuyninum and Tween 80, add to the full amount of water for injection after placing room temperature, add 0.2% active carbon, at 70 ℃ of absorption down, decarbonization filtering; Gained filtrate is continued with 0.22 μ m filtering with microporous membrane, packing, lyophilization.The vacuum lyophilization condition:
1) pre-freeze: the medicine that branch is installed is put into and is carried out pre-freeze on the freeze drying box internal partition, and products temperature drops to-45 ℃, keeps promptly can carrying out sublimation drying after 3.5 hours.
2) sublimation drying: the vacuum in the drying baker reaches 13.33Pa (0.1mmHg) when following, closes fridge, slowly heats by the heating system under the dividing plate, and temperature is controlled at below-20 ℃, and the sublimation drying time is 15 hours.
3) dry again: the drying stage temperature is controlled at below 15 ℃ again, and be 10 hours drying time again.
Embodiment 2
Prescription: neo-houttuyninum 10g
Tween 80 50g
Mannitol 250g
Glucose 50g
Water for injection adds to 5000ml
Make 1000 altogether
Method for making: with neo-houttuyninum and polyoxyethylene sorbitan monoleate mix homogeneously, the manna alcohol and glucose is dissolved into boil in the water for injection of 4500ml after, join stirring and dissolving in the mixed liquor of aforesaid neo-houttuyninum and Tween 80, add to the full amount of water for injection after placing room temperature, add 0.2% active carbon, at 70 ℃ of absorption down, decarbonization filtering; Gained filtrate is continued with 0.22 μ m filtering with microporous membrane, packing, lyophilization.The vacuum lyophilization condition:
1) pre-freeze: the medicine that branch is installed is put into and is carried out pre-freeze on the freeze drying box internal partition, and products temperature drops to-45 ℃, keeps promptly can carrying out sublimation drying after 3.5 hours.
2) sublimation drying: the vacuum in the drying baker reaches 13.33Pa (0.1mmHg) when following, closes fridge, slowly heats by the heating system under the dividing plate, and temperature is controlled at below-20 ℃, and the sublimation drying time is 15 hours.
3) dry again: the drying stage temperature is controlled at below 15 ℃ again, and be 10 hours drying time again.
Embodiment 3
Prescription: neo-houttuyninum 20g
Tween 80 100g
Mannitol 500g
Glucose 100g
Water for injection adds to 10000ml
Make 1000 altogether
Method for making: with neo-houttuyninum and polyoxyethylene sorbitan monoleate mix homogeneously, the manna alcohol and glucose is dissolved into boil in the water for injection of 9000ml after, join stirring and dissolving in the mixed liquor of aforesaid neo-houttuyninum and Tween 80, add to the full amount of water for injection after placing room temperature, add 0.2% active carbon, at 70 ℃ of absorption down, decarbonization filtering; Gained filtrate is continued with 0.22 μ m filtering with microporous membrane, packing, lyophilization.The vacuum lyophilization condition:
1) pre-freeze: the medicine that branch is installed is put into and is carried out pre-freeze on the freeze drying box internal partition, and products temperature drops to-45 ℃, keeps promptly can carrying out sublimation drying after 3.5 hours.
2) sublimation drying: the vacuum in the drying baker reaches 13.33Pa (0.1mmHg) when following, closes fridge, slowly heats by the heating system under the dividing plate, and temperature is controlled at below-20 ℃, and the sublimation drying time is 15 hours.
3) dry again: the drying stage temperature is controlled at below 15 ℃ again, and be 10 hours drying time again.
Embodiment 4
Prescription: neo-houttuyninum 10g
Tween 80 75g
Mannitol 250g
Glucose 50g
Water for injection adds to 5000ml
Make 1000 altogether
Method for making: with neo-houttuyninum and polyoxyethylene sorbitan monoleate mix homogeneously, the manna alcohol and glucose is dissolved into boil in the water for injection of 4500ml after, join stirring and dissolving in the mixed liquor of aforesaid neo-houttuyninum and Tween 80, add to the full amount of water for injection after placing room temperature, add 0.2% active carbon, at 70 ℃ of absorption down, decarbonization filtering; Gained filtrate is continued with 0.22 μ m filtering with microporous membrane, packing, lyophilization.The vacuum lyophilization condition:
1) pre-freeze: the medicine that branch is installed is put into and is carried out pre-freeze on the freeze drying box internal partition, and products temperature drops to-45 ℃, keeps promptly can carrying out sublimation drying after 3.5 hours.
2) sublimation drying: the vacuum in the drying baker reaches 13.33Pa (0.1mmHg) when following, closes fridge, slowly heats by the heating system under the dividing plate, and temperature is controlled at below-20 ℃, and the sublimation drying time is 35 hours.
3) dry again: the drying stage temperature is controlled at below 15 ℃ again, and be 10 hours drying time again.
Embodiment 5
Prescription: neo-houttuyninum 10g
Tween 80 50g
Mannitol 100g
Glucose 20g
Water for injection adds to 5000ml
Make 1000 altogether
Method for making: with neo-houttuyninum and polyoxyethylene sorbitan monoleate mix homogeneously, the manna alcohol and glucose is dissolved into boil in the water for injection of 4500ml after, join stirring and dissolving in the mixed liquor of aforesaid neo-houttuyninum and Tween 80, add to the full amount of water for injection after placing room temperature, add 0.2% active carbon, at 70 ℃ of absorption down, decarbonization filtering; Gained filtrate is continued with 0.22 μ m filtering with microporous membrane, packing, lyophilization.The vacuum lyophilization condition:
1) pre-freeze: the medicine that branch is installed is put into and is carried out pre-freeze on the freeze drying box internal partition, and products temperature drops to-45 ℃, keeps promptly can carrying out sublimation drying after 3.5 hours.
2) sublimation drying: the vacuum in the drying baker reaches 13.33Pa (0.1mmHg) when following, closes fridge, slowly heats by the heating system under the dividing plate, when temperature rises to-20 ℃, open when refrigerator temps is reduced to-45 ℃ and close fridge, so repeatedly, the sublimation drying time is 35 hours.
3) dry again: the drying stage temperature is controlled at below 15 ℃ again, and be 10 hours drying time again.
Embodiment 6
Prescription: neo-houttuyninum 10g
Tween 80 100g
Mannitol 400g
Glucose 200g
Water for injection adds to 5000ml
Make 1000 altogether
Method for making: with neo-houttuyninum and polyoxyethylene sorbitan monoleate mix homogeneously, the manna alcohol and glucose is dissolved into boil in the water for injection of 4500ml after, join stirring and dissolving in the mixed liquor of aforesaid neo-houttuyninum and Tween 80, add to the full amount of water for injection after placing room temperature, add 0.2% active carbon, at 70 ℃ of absorption down, decarbonization filtering; Gained filtrate is continued with 0.22 μ m filtering with microporous membrane, packing, lyophilization.The vacuum lyophilization condition:
1) pre-freeze: the medicine that branch is installed is put into and is carried out pre-freeze on the freeze drying box internal partition, and products temperature drops to-45 ℃, keeps promptly can carrying out sublimation drying after 3.5 hours.
2) sublimation drying: the vacuum in the drying baker reaches 13.33Pa (0.1mmHg) when following, closes fridge, slowly heats by the heating system under the dividing plate, and temperature is controlled at below-20 ℃, and the sublimation drying time is 15 hours.
3) dry again: the drying stage temperature is controlled at below 15 ℃ again, and be 10 hours drying time again.
Embodiment 7
Prescription: neo-houttuyninum 10g
Tween 80 50g
Mannitol 400g
Water for injection adds to 5000ml
Make 1000 altogether
Method for making: with neo-houttuyninum and polyoxyethylene sorbitan monoleate mix homogeneously, mannitol is dissolved into boil in the water for injection of 4500ml after, join stirring and dissolving in the mixed liquor of aforesaid neo-houttuyninum and Tween 80, add to the full amount of water for injection after placing room temperature, add 0.2% active carbon, at 70 ℃ of absorption down, decarbonization filtering; Gained filtrate is continued with 0.22 μ m filtering with microporous membrane, packing, lyophilization.The vacuum lyophilization condition:
1) pre-freeze: the medicine that branch is installed is put into and is carried out pre-freeze on the freeze drying box internal partition, and products temperature drops to-45 ℃, keeps promptly can carrying out sublimation drying after 3.5 hours.
2) sublimation drying: the vacuum in the drying baker reaches 13.33Pa (0.1mmHg) when following, closes fridge, slowly heats by the heating system under the dividing plate, when temperature rises to-20 ℃, open when refrigerator temps is reduced to-45 ℃ and close fridge, so repeatedly, the sublimation drying time is 35 hours.
3) dry again: the drying stage temperature is controlled at below 15 ℃ again, and be 10 hours drying time again.
Embodiment 8
Prescription: neo-houttuyninum 10g
Tween 80 35g
Mannitol 400g
Water for injection adds to 5000ml
Make 1000 altogether
Method for making: with neo-houttuyninum and polyoxyethylene sorbitan monoleate mix homogeneously, mannitol is dissolved into boil in the water for injection of 4500ml after, join stirring and dissolving in the mixed liquor of aforesaid neo-houttuyninum and Tween 80, add to the full amount of water for injection after placing room temperature, add 0.1% active carbon, at 70 ℃ of absorption down, decarbonization filtering; Gained filtrate is continued with 0.22 μ m filtering with microporous membrane, packing, lyophilization.The vacuum lyophilization condition:
1) pre-freeze: the medicine that branch is installed is put into and is carried out pre-freeze on the freeze drying box internal partition, and products temperature drops to-45 ℃, keeps promptly can carrying out sublimation drying after 3.5 hours.
2) sublimation drying: the vacuum in the drying baker reaches 13.33Pa (0.1mmHg) when following, closes fridge, slowly heats by the heating system under the dividing plate, when temperature rises to-20 ℃, open when refrigerator temps is reduced to-45 ℃ and close fridge, so repeatedly, the sublimation drying time is 35 hours.
3) dry again: the drying stage temperature is controlled at below 15 ℃ again, and be 10 hours drying time again.
Claims (10)
1, a kind of freeze-dried composition of neo-houttuyninum, comprising the treatment effective dose neo-houttuyninum and can cryodesiccated additives.
2, pharmaceutical composition as claimed in claim 1, wherein the consumption of neo-houttuyninum is 0.05～0.5% of the prescription solution amount.
3, pharmaceutical composition as claimed in claim 1, wherein to contain the amount of neo-houttuyninum be 1～100mg to each unit formulation.
4, pharmaceutical composition as claimed in claim 1, wherein to contain the amount of neo-houttuyninum be 4～20mg to each unit formulation.
5, pharmaceutical composition as claimed in claim 1 wherein can comprise Tween 80 and diluent by cryodesiccated additives.
6, pharmaceutical composition as claimed in claim 5, wherein the consumption of Tween 80 is 0.5%～2.5% of the prescription solution amount.
7, pharmaceutical composition as claimed in claim 5, wherein diluent is selected from a kind of or mixture of mannitol, lactose, dextran, glucose, glycine, gelatin hydrolysate, polyvidone etc.
8, pharmaceutical composition as claimed in claim 5, wherein the consumption of diluent is 2%～15% of the prescription solution amount
9, pharmaceutical composition as claimed in claim 5, wherein diluent is mannitol and glucose mixture.
10, pharmaceutical composition as claimed in claim 9, wherein the mixed proportion of mannitol and glucose mixture is 1～8: 1.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200410000862 CN1640390A (en) | 2004-01-17 | 2004-01-17 | Novel sodium houttuynin lyophilized powder for injection and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200410000862 CN1640390A (en) | 2004-01-17 | 2004-01-17 | Novel sodium houttuynin lyophilized powder for injection and its preparing method |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2477030A (en) * | 2010-01-15 | 2011-07-20 | Lithera Inc | Lyophilised forms of fluticasone, salmeterol and combinations thereof |
| CN101491678B (en) * | 2009-02-25 | 2011-09-28 | 正大青春宝药业有限公司 | Preparation method of injector using tween-80 as solubilizer |
| US8404750B2 (en) | 2009-05-27 | 2013-03-26 | Lithera, Inc. | Methods for administration and formulations for the treatment of regional adipose tissue |
| US8420625B2 (en) | 2005-07-14 | 2013-04-16 | Lithera, Inc | Lipolytic methods for regional adiposity |
-
2004
- 2004-01-17 CN CN 200410000862 patent/CN1640390A/en active Pending
Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8420625B2 (en) | 2005-07-14 | 2013-04-16 | Lithera, Inc | Lipolytic methods for regional adiposity |
| US9198885B2 (en) | 2005-07-14 | 2015-12-01 | Neothetics, Inc. | Lipolytic methods for regional adiposity comprising salmeterol or formoterol |
| US9370498B2 (en) | 2005-07-14 | 2016-06-21 | Neothetics, Inc. | Methods of using lipolytic formulations for regional adipose tissue treatment |
| US9452147B2 (en) | 2005-07-14 | 2016-09-27 | Neothetics, Inc. | Lipolytic methods |
| US9707192B2 (en) | 2005-07-14 | 2017-07-18 | Neothetics, Inc. | Lipolytic methods |
| CN101491678B (en) * | 2009-02-25 | 2011-09-28 | 正大青春宝药业有限公司 | Preparation method of injector using tween-80 as solubilizer |
| US8404750B2 (en) | 2009-05-27 | 2013-03-26 | Lithera, Inc. | Methods for administration and formulations for the treatment of regional adipose tissue |
| US9132084B2 (en) | 2009-05-27 | 2015-09-15 | Neothetics, Inc. | Methods for administration and formulations for the treatment of regional adipose tissue |
| US9452132B2 (en) | 2009-05-27 | 2016-09-27 | Neothetics, Inc. | Methods for administration and formulations for the treatment of regional adipose tissue |
| GB2477030A (en) * | 2010-01-15 | 2011-07-20 | Lithera Inc | Lyophilised forms of fluticasone, salmeterol and combinations thereof |
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