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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: 2005-07-06
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 drying...

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 into a paste, add 3L of water for injection at 70°C to 85°C, control the temperature at 70°C to 85°C 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 decarbonize, 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 s...

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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Abstract

The new houttuyfonate sodium freeze-dried powder for injection and a preparation method thereof belong to the technical field of medicine. The freeze-dried powder injection of new houttuyfonate sodium contains the following components: 0.01% to 40% of new houttuyniatin sodium, 0.01% to 95% of one or more of cyclodextrin or cyclodextrin derivatives, excipient Forming agent 0~97%. The preparation method comprises: dissolving neohouttuydin sodium, cyclodextrin or cyclodextrin derivatives in water for injection, adding excipients to dissolve, adjusting the pH value, filtering the solution, subpackaging the filtrate, freezing, sublimating and drying to obtain white Loose block or powder product. The freeze-dried powder injection of the present invention has good solubility, no irritating smell, high bioavailability and good stability, making clinical use safer and more convenient, and can be used for intramuscular injection or intravenous infusion, and is used for treating pelvic inflammatory disease, adnexitis, Gynecological inflammation such as chronic cervicitis.

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 Patents(China)
IPC IPC(8): A61K9/19A61K31/255A61P15/00A61P29/00
Inventor 肖广常张颖
Owner 肖广常
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