Method for preparing medicinal accessories sodium caprylate

A pharmaceutical excipient, sodium caprylate technology, applied in carboxylate preparation, organic chemistry, etc., can solve problems such as poor solubility, large particles, and poor clarity, and achieve simple process, high quality, and protection from The effect of pyrolysis

Active Publication Date: 2009-10-07
北京市师化精细化工科技开发有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] At present, most of the sodium octanoate products on the market are chemical reagents with large particles, poor solubility in water and poor clarity, and can only be used in fine chemical products and other fields.
Sodium octanoate used in the field of biological products and medicine must meet the quality control standards of pharmaceutical excipients to ensure the quality and stability of finished drugs. So far, no sodium octanoate prepared by a preparation method can meet or exceed the quality control standards of pharmaceutical excipients. standard

Method used

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  • Method for preparing medicinal accessories sodium caprylate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] The preparation method of pharmaceutical adjuvant sodium caprylate described in the present embodiment, it may further comprise the steps:

[0045] ①Distillation purification and purification of octanoic acid:

[0046] Put the industrial octanoic acid into the acid distillation tank, use a vacuum pump to reduce the pressure in the system to 0.07Mpa, and carry out distillation at a temperature of 135°C. After the acid vapor enters the condenser to cool, the purified octanoic acid is separated and set aside;

[0047] ② Synthesis of sodium octanoate:

[0048] Dissolve 20Kg of sodium hydroxide in 140L of pure water. After completely dissolving, add 72Kg of purified caprylic acid while stirring. Heat the temperature to 80°C. After full reaction, sodium caprylate will be generated, and the pH value will be controlled at 8.5;

[0049] ③Spray drying:

[0050] After the sodium caprylate solution was allowed to stand, it was filtered to remove trace impurities, and then centrif...

Embodiment 2

[0058] The preparation method of pharmaceutical adjuvant sodium caprylate described in the present embodiment, it may further comprise the steps:

[0059] ①Distillation purification and purification of octanoic acid:

[0060] Put the industrial octanoic acid into the acid distillation tank, reduce the pressure in the system to 0.08Mpa with a vacuum pump, and carry out distillation at a temperature of 145°C. After the acid vapor enters the condenser to cool, the purified octanoic acid is separated and set aside;

[0061] ② Synthesis of sodium octanoate:

[0062] Dissolve 30Kg of sodium hydroxide in 180L of pure water. After completely dissolving, add 108Kg of purified caprylic acid while stirring. Heat the temperature to 100°C. After full reaction, sodium caprylate will be generated, and the pH value will be controlled at 9.5;

[0063] ③Spray drying:

[0064] After the sodium caprylate solution was allowed to stand, it was filtered to remove trace impurities, and then it was ce...

Embodiment 3

[0072] The preparation method of pharmaceutical adjuvant sodium caprylate described in the present embodiment, it may further comprise the steps:

[0073] ①Distillation purification and purification of octanoic acid:

[0074] Put the industrial octanoic acid into the acid distillation tank, reduce the pressure in the system to 0.10Mpa with a vacuum pump, and carry out distillation at a temperature of 150°C. After the acid vapor enters the condenser to cool down, separate the purified octanoic acid for later use;

[0075] ② Synthesis of sodium octanoate:

[0076] Dissolve 15Kg of sodium hydroxide in 130L of pure water. After completely dissolving, add 54Kg of purified caprylic acid while stirring, and heat the temperature to 110°C. After full reaction, sodium caprylate will be generated, and the pH value will be controlled at 10;

[0077] ③Spray drying:

[0078] The sodium octanoate solution was left to stand and then filtered to remove trace impurities, then centrifugally sp...

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Abstract

The invention relates to a preparation method of sodium octanoate as a medicinal auxiliary material. It includes the following steps: put industrial octanoic acid into an acid distillation tank, use a vacuum pump to reduce the pressure to 0.06-0.10MPa, and carry out distillation at a temperature of 130-150°C. After the acid vapor enters a condenser to cool, separate the purified Caprylic acid: put sodium hydroxide and pure water into the reaction tank at a ratio of 1:6~9, add octanoic acid in an equal amount while stirring, heat the temperature to 60~110°C, and generate sodium caprylate after fully reacting , the pH value is controlled within the range of 8 to 10.5; then the sodium caprylate solution is left to stand, filtered, and centrifugally sprayed and dried into a white crystalline powder; after passing the inspection, it is sealed and packaged to produce a finished product. The advantages of the present invention are: the sodium caprylate prepared by the present invention has good stability, high purity, is easily soluble in water, has good solution clarity, and the pyrogen quality is qualified and other quality control standards reach the level of the sodium caprylate pharmaceutical auxiliary material. It can be used in biological products and pharmaceutical industries to make finished drugs with high quality and good stability.

Description

technical field [0001] The invention relates to a preparation method of sodium octanoate as a pharmaceutical auxiliary material. Background technique [0002] Sodium octanoate products currently on the market are mostly chemical reagents with large particles, poor solubility in water, and poor clarity, so they can only be used in fine chemical products and other fields. Sodium caprylate used in the field of biological products and medicine must meet the quality control standards of pharmaceutical excipients to ensure the quality and stability of finished drugs. So far, no sodium caprylate prepared by a preparation method has been found that can meet or exceed the quality control standards of pharmaceutical excipients. standard. Contents of the invention [0003] The purpose of the present invention is to provide a preparation method of high-purity pharmaceutical excipient sodium caprylate which is suitable for use in industries such as biological products and medicine, an...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07C51/41C07C53/128A61K47/12
Inventor 王少亭
Owner 北京市师化精细化工科技开发有限责任公司
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