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Neohouttuynin sodium freeze-dried powder-injection, and its prepn. method

A new technology of houttuynia sodium and freeze-dried powder injection can be applied in the field of medicine, which can solve the problems of inconvenience, easy precipitation, unstable storage period and the like, and achieve the effects of reducing irritation, prolonging storage period and improving bioavailability.

Inactive Publication Date: 2003-12-03
肖广常 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This has brought inconvenience for the clinical use of this medicine, has also illustrated the shortcoming of this medicine simultaneously: unstable in storage period, easy to separate out

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1: Neohouttuydin Sodium Freeze-Dried Powder for Injection, the components are as follows, all in percent by weight:

[0025] Neohouttuydin Sodium 2.0%

[0026] Hydroxypropyl-beta-cyclodextrin 22.6%

[0027] Mannitol 75.4%

[0028] The preparation method is as follows:

[0029] Take 12g of new houttuyfonate sodium raw material, 135g of hydroxypropyl-β-cyclodextrin, add 3L of water for injection, stir into a paste, add 3L of water for injection at 70℃~85℃, and control the temperature at 70℃ when dissolving At ~85°C, add 450g of mannitol to dissolve, then adjust the pH value to 5.6 with 1moL / L hydrochloric acid solution, add charcoal for needles, stir at room temperature, filter to remove carbon, and fine filter. The filtrate is divided into 2ml per bottle, and the quick-freezing method is used to reduce the temperature by 10°C per minute until the solution cools down to -45°C and maintain for 4 hours, then warm to -20°C, carry out sublimation ...

Embodiment 2

[0030] Example 2: Neohouttuydin Sodium Freeze-Dried Powder for Injection, the components are as follows, all in percent by weight:

[0031] Neohouttuydin Sodium 4.3%

[0032] Alpha-Cyclodextrin 53.2%

[0033] Lactose 42.5%.

[0034] The preparation method is as follows:

[0035] Take 30g of new houttuyniatin sodium raw material, 375g of α-cyclodextrin, add 3L of water for injection, stir it into a paste, add 3L of water for injection at 70℃~85℃, control the temperature at 70℃~85℃ when dissolving , add 300g of lactose to dissolve, then adjust the pH value to 4.8 with 1moL / L hydrochloric acid solution, add charcoal for needles, stir at room temperature, filter to remove carbon, and fine filter. The filtrate is divided into 2ml per bottle, and the quick-freezing method is used to reduce the temperature by 10°C per minute until the solution cools down to -40°C and maintain for 4 hours, then warm to -20°C, carry out sublimation drying, take out the product, and...

Embodiment 3

[0036] Example 3: Neohouttuydin Sodium Freeze-Dried Powder for Injection, the components are as follows, all in percent by weight:

[0037] Neohouttuydin Sodium 5.7%

[0038] Gamma-cyclodextrin 65.7%

[0039] Glucose 28.5%

[0040] The preparation method is as follows:

[0041] Take 60g of new houttuyniatin sodium raw material, 690g of γ-cyclodextrin, add 3L of water for injection, stir it into a paste, add 3L of water for injection at 70℃~85℃, control the temperature at 70℃~85℃ when dissolving, Add 300g of glucose to dissolve, then adjust the pH value to 6.2 with 1moL / L hydrochloric acid solution, add charcoal for needles, stir at room temperature, filter to remove carbon, and fine filter. The filtrate is divided into 2ml per bottle, and the quick-freezing method is used to reduce the temperature by 15°C per minute until the solution cools down to -45°C and maintain for 4 hours, then warm to -30°C, carry out sublimation drying, take out the product, and seal it...

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PUM

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Abstract

A freeze-dried powder injection of neohouttuynine sodium for treating pelvic inflammation, annexitis and chronic cervicitis contains neohouttuynine sodium, one or more of cyclodextrin and its derivatives and excipient in a certain proportion. It is prepared through dissolving neohouttuynine sodium and cyclodextrin or its derivative in the water for injection, adding excipient, regulating the pH value, filtering, freezing, and sublimation drying.

Description

(1) Technical field [0001] The invention relates to a freeze-dried powder injection of neohouttuyfonate sodium for injection and a preparation method thereof, belonging to the technical field of medicine. (2) Background technology [0002] Neohouttuydin Sodium is a synthetic product with the chemical name sodium laurylacetaldehyde bisulfite. This product is easily soluble in hot water, slightly soluble in water and ethanol, almost insoluble in chloroform and benzene, and almost insoluble in hydrogen Sodium oxide is easily soluble in the test solution, but it decomposes at the same time (National Drug Standard Chemical Drug Local Standard Rising National Standard Volume 5 P273). Moreover, the new houttuyfonate sodium has a fishy smell and a slight odor. The above-mentioned characteristics make its preparation and application subject to certain restrictions. [0003] The usage and dosage of the instructions of the new houttuybein sodium injection in the national drug standard...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/255A61P15/00A61P29/00
Inventor 肖广常张颖
Owner 肖广常
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