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Novel sodium houttuynin lyophilized powder for injection and its preparing method

A new houttuyfonate sodium and freeze-drying technology, which can be used in freeze-dried transportation, medical preparations containing active ingredients, powder transportation, etc., can solve the problems of high cost, deduction, complicated process, etc., and achieve the convenience of clinical use , loose texture, fast redissolving effect

Inactive Publication Date: 2005-07-20
BEIJING BOERDA BIO TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patents CN1459284 and CN1449834 are both freeze-dried powder injection forms of neohouttuydin sodium, both of which use β-cyclodextrin or its derivatives as a cosolvent. At present, due to the toxicity of cyclodextrin and its derivatives Such problems have not yet been approved as an auxiliary material for injection in China, and Tween 80 has been used as an auxiliary material for injection for a long time. The process of preparing injections with combined drugs is complex and costly
Chinese patent CN1404825 discloses a preparation method for intravenous injection of new houttuyfonate sodium, which uses Tween 80 as a solubilizer, but because new houttuybein sodium is insoluble in water and Tween 80 has a relatively high viscosity, this Those skilled in the art cannot deduce from common sense based on CN1404825 that Tween 80 can be used as a solubilizer to make neohouttuyfonate sodium into a freeze-dried powder injection with loose texture, good appearance and rapid redissolution

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Prescription: New Houttuyfonate Sodium 4g

[0017] Tween-80 20g

[0018] Mannitol 100g

[0019] Glucose 20g

[0020] Add water for injection to 2000ml

[0021] A total of 1000 pieces

[0022] Preparation method: Mix the new houttuyfonate sodium and polysorbate 80 uniformly, dissolve mannitol and glucose in 1800ml of water for injection, boil, and add to the aforementioned mixture of new houttuyfonate sodium and Tween 80 Stir to dissolve, add water for injection to full volume after standing at room temperature, add 0.2% activated carbon, adsorb at 70°C, decarburize and filter; the obtained filtrate is continuously filtered with 0.22μm microporous membrane, packed and freeze-dried. Vacuum freeze drying conditions:

[0023] 1) Pre-freezing: Put the packaged medicines on the partition in the freeze-drying box for pre-freezing, the product temperature drops to -45°C, and after holding for 3.5 hours,...

Embodiment 2

[0027] Prescription: New Houttuyfonate Sodium 10g

[0028] Tween-80 50g

[0029] Mannitol 250g

[0030] Glucose 50g

[0031] Add water for injection to 5000ml

[0032] A total of 1000 pieces

[0033] Preparation method: Mix the new houttuyfonate sodium and polysorbate 80 uniformly, dissolve mannitol and glucose in 4500ml of water for injection, boil, and add to the aforementioned mixture of new houttuyfonate sodium and Tween 80 Stir to dissolve, add water for injection to full volume after standing at room temperature, add 0.2% activated carbon, adsorb at 70°C, decarburize and filter; the obtained filtrate is continuously filtered with 0.22μm microporous membrane, packed and freeze-dried. Vacuum freeze drying conditions:

[0034] 1) Pre-freezing: Put the packaged medicines on the partition in the freeze-drying box for pre-freezing, the product temperature drops to -45°C, and after holding for 3.5 hours, it ...

Embodiment 3

[0038] Prescription: New Houttuyfonate Sodium 20g

[0039]Tween-80 100g

[0040] Mannitol 500g

[0041] Glucose 100g

[0042] Add water for injection to 10000ml

[0043] A total of 1000 pieces

[0044] Preparation method: Mix the new houttuyfonate sodium and polysorbate 80 uniformly, dissolve mannitol and glucose in 9000ml of water for injection, boil, and add to the aforementioned mixture of new houttuyfonate sodium and Tween 80 Stir to dissolve, add water for injection to the full amount after standing at room temperature, add 0.2% activated carbon, adsorb at 70°C, decarburize and filter; the obtained filtrate is continuously filtered with 0.22μm microporous membrane, packed and freeze-dried. Vacuum freeze-drying conditions:

[0045] 1) Pre-freezing: Put the packaged drugs on the partition in the freeze-drying box for pre-freezing, the product temperature drops to -45°C, and after holding for 3.5 hours, it can be sublimated and dried.

[0046]...

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PUM

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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 [0001] The invention relates to a pharmaceutical preparation, in particular a new houttuyfonate sodium freeze-dried powder injection and a preparation method. Background technique [0002] The adduct of lauryl acetaldehyde sodium bisulfite is called new houttuyfonate, which is a synthetic product. The pharmacological effect is similar to that of Houttuyfonate (sodium bisulfite adduct of decanoyl acetaldehyde), and it has the strongest in vitro inhibitory effect on Staphylococcus aureus and its penicillin-resistant strains, pneumococcus, streptococcus A and influenza bacillus; It also has a certain inhibitory effect on catarrhalis, typhoid bacillus, Escherichia coli and tuberculosis bacillus. In addition, it is effective against a variety of skin pathogenic fungi. Clinically used for gynecological inflammation such as pelvic inflammatory disease, adnexitis, chronic cervicitis. [0003] The currently marketed new houttuyfonate sodium has only one dosage form for inj...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/255A61P15/00A61P31/04
Inventor 张成飞张金城
Owner BEIJING BOERDA BIO TECH DEV
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