Novel sodium houttuyfonate compound as well as preparation method and pharmaceutical composition thereof

A new houttuyfonate sodium and compound technology, which is applied in the field of medicine, can solve the problems such as the need to improve the purity, and achieve the effect of safe and reliable clinical application and a small amount of solvent content

Inactive Publication Date: 2013-08-28
四川省惠达药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] "Spectroscopy Study on the Confirmation of the Structure of New Houttuyfonate Sodium" (Lan Yumei et al., "Chinese Pharmacy", 2012) also disclosed that the repeated recrystallization of New Houttuyfonate Sodium with 95% ethanol resulted in white scales. Crystal, the purity still needs to be improved

Method used

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  • Novel sodium houttuyfonate compound as well as preparation method and pharmaceutical composition thereof
  • Novel sodium houttuyfonate compound as well as preparation method and pharmaceutical composition thereof
  • Novel sodium houttuyfonate compound as well as preparation method and pharmaceutical composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Example 1: Preparation of new Houttuyrin sodium compound

[0046] 1. Prepare 5L of a saturated solution of new Houttuynia sodium crude product at 55°C, stir until completely dissolved;

[0047] 2. In a sound field with a frequency of 25KHz and an output power of 60W, add 50L of a mixed solution of isopropanol and acetone at 5°C while stirring. After the mixed solution is added, stop stirring and continue to cool down under the action of the sound field to 1 When the temperature is ℃, the sound field is stopped, and the crystals are allowed to stand for 24 hours under the condition of 0 ℃. After the crystals are precipitated, they are washed and dried to obtain the new houttuyniacin sodium compound. Wherein, the adding speed of the mixed solution of isopropanol and acetone is: v 1 =500 ml / min; the volume ratio of isopropanol and acetone is 5:1; after the mixed solvent is added, the speed of cooling is v 2 =5°C / hour.

[0048] The crystal of the compound was detected by...

Embodiment 2

[0049] Example 2: Preparation of new houttuyrin sodium compound

[0050] 1. Prepare 5L of a saturated solution of new Houttuyrin sodium crude product at 70°C, stir until completely dissolved;

[0051] 2. In a sound field with a frequency of 20KHz and an output power of 40W, add 10L of a mixed solution of isopropanol and acetone at 0°C while stirring, stop stirring after the mixed solution is added, and continue to cool down under the action of the sound field to 1 When the temperature is ℃, the sound field is stopped, and the crystals are allowed to stand for 24 hours under the condition of 0 ℃. After the crystals are precipitated, they are washed and dried to obtain the new houttuyniacin sodium compound. Wherein, the adding speed of the mixed solution of isopropanol and acetone is: v 1 =100 ml / min; the volume ratio of isopropanol and acetone is 5:2; after the mixed solvent is added, the speed of cooling is v 2 =2°C / hour.

[0052] The crystal of the compound was detected by...

Embodiment 3

[0053] Example 3: Preparation of new houttuyrin sodium compound freeze-dried powder injection

[0054] Formulation: 10 g of the new houttuyniacin sodium compound prepared in Example 1, 20 g of polysorbate-800, 40 g of mannitol, and 0.1 g of meglumine;

[0055] Preparation:

[0056] 1. The polysorbate-80 of the recipe quantity is stirred and dissolved with water for injection at a temperature of 45 ℃, then the new houttuyniacin sodium compound of the recipe quantity is added, and stirring and dissolving; after adding excipient and meglumine, stirring and dissolving to room temperature;

[0057] 2. Adjust the pH value to 5.0-6.0, add medicinal activated carbon with a mass percentage of 0.01%, adsorb for 20 minutes, filter and decarbonize; fine filter, add sterile water for injection to 2500ml, fine filter;

[0058] 3. Freeze-drying: freeze-dry the filtrate obtained in step 2, divide it into 2500 pieces under aseptic conditions, press lid, and seal with aluminum, and then obtai...

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Abstract

The invention relates to the field of medicines and particularly relates to a novel sodium houttuyfonate compound as well as a preparation method and pharmaceutical composition thereof. The novel sodium houttuyfonate compound provided by the invention is shown as the structural formula (I), and an X-ray powder diffraction map obtained through measuring by using Cu-K alpha rays is shown as the drawing I. The novel sodium houttuyfonate compound provided by the invention is high in purity, good in stability and safe and reliable in clinical application.

Description

technical field [0001] The invention relates to the field of medicine, in particular, to a new houttuyrin sodium compound, a preparation method thereof and a pharmaceutical composition thereof. Background technique [0002] Sodium lauroyl-α-hydroxyethyl sulfonate, the chemical name of sodium lauroyl-α-hydroxyethyl sulfonate, is the addition of lauroylacetaldehyde and sodium bisulfite, the single active ingredient of Houttuynia cordata. The finished product has antibacterial, anti-inflammatory and antiviral activities, and its injection can be used for clinical treatment of pneumonia, lung abscess, upper respiratory tract infection and gynecological inflammation such as adnexitis, cervicitis, and pelvic inflammatory disease. Since Houttuynia cordata injection is a mixture of various volatile oils, adverse reactions are prone to occur in clinical use, and its market share shrinks sharply; while the new Houttuyniacin sodium injection has a single component and low side effects,...

Claims

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Application Information

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IPC IPC(8): C07C309/08C07C303/44A61K31/185A61K9/19A61K9/08A61P31/00A61P31/12A61P29/00
Inventor 梁宏平
Owner 四川省惠达药业有限公司
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