A gastrodin compound and its pharmaceutical composition

A technology of gastrodin and its compounds, which is applied in the field of gastrodin compounds and their pharmaceutical compositions, can solve the problems of complicated process, unstable related substances, unstable pH value of gastrodin compounds, etc., achieve simple prescription process, improve safety and Effectiveness, stability improvement effect

Active Publication Date: 2015-09-09
湖北美林药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation of gastrodin in this application requires microwave and magnetic field control, and the process is extremely complicated, and we found in the test that the pH value of the gastrodin compound prepared in this application is unstable, and the related substances are also unstable, and the increase is relatively fast, which increases the gastrodin compound. Use of security risks
As can be seen from this, the prior art does not fully solve the existing problems of gastrodin, which limits the clinical use of gastrodin

Method used

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  • A gastrodin compound and its pharmaceutical composition
  • A gastrodin compound and its pharmaceutical composition
  • A gastrodin compound and its pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Example 1 Preparation of gastrodin compound

[0051] Gastrodin (commercially available gastrodin raw material, Jiangsu Hanstone Pharmaceutical Co., Ltd.) was dissolved in ethanol and methanol with a volume ratio of 2:1 at a weight ratio of 1:8 at a stirring speed of 150 rpm at 20°C. In the mixed solution; keep at 20°C, add activated carbon with 1.0% gastrodin by weight, stir at 150 rpm for 25 minutes, filter to remove the carbon, filter the filtrate through a 0.22 μm filter membrane; 25°C, at a stirring speed of 100 rpm , while stirring at a speed of 40ml / min, slowly and uniformly dripped the mixed solution of chloroform and ether with a volume ratio of 4:1 whose weight is 7 times of the mixture of ethanol and methanol; , cooled to 2°C at a rate of 0.1°C / min for 10 hours, and filtered; the filter cake obtained by filtration was washed twice with a mixed solution of chloroform and ether with a volume ratio of 3 times the weight of 4:1, and dried. That is, the gastrodin ...

Embodiment 2

[0052] Example 2 Preparation of gastrodin compound

[0053] Gastrodin (commercially available gastrodin raw material, Jiangsu Hanstone Pharmaceutical Co., Ltd.) was dissolved in ethanol and methanol with a volume ratio of 2:1 at a weight ratio of 1:10 at a stirring speed of 200 rpm at 25°C. In the mixed solution; keep at 25°C, add activated carbon with 1.0% gastrodin by weight, stir at 200 rpm for 25 minutes, filter to remove the carbon, filter the filtrate through a 0.22 μm filter membrane; 30°C, at a stirring speed of 150 rpm , while stirring, slowly and uniformly dropwise at a speed of 50ml / min the mixed solution of chloroform and ether with a volume ratio of 4:1 that is 9 times the weight of the mixture of ethanol and methanol; , cooled to 4°C at a rate of 0.2°C / min for 10 hours, and filtered; the filter cake obtained by filtration in 4 was washed twice with a mixed solution of chloroform and ether with a volume ratio of 3 times the weight of 4:1. After drying, the gastro...

Embodiment 3

[0054] Example 3 Preparation of gastrodin lyophilized powder for injection (specification: 0.1g)

[0055] prescription:

[0056] The gastrodin compound prepared in Example 1 100g

[0057] Mannitol 60g

[0058] Water for injection 2000ml

[0059] ____________________________________

[0060] 1000 pieces

[0061] Craft:

[0062] 1. Add the prescribed amount of gastrodin to 70% of the water for injection, stir and dissolve at 30°C, add water for injection to 80%, then add mannitol according to the prescribed amount, stir and dissolve, add water for injection to the full amount, and stir well.

[0063] 2. Add 0.15% activated carbon to 1, stir for 20 minutes, filter and decarbonize, filter and sterilize with 0.22 μm filter membrane, and conduct intermediate detection.

[0064] 3. Freeze-dried:

[0065] ①Pre-freezing: divide the 2 filtrates into half plugs and place them in a freezer that is pre-cooled to -25°C, keep for 1 hour, cool down to -35°C at a speed of 0.2°C / min, and...

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Abstract

The invention relates to a gastrodine compound and a pharmaceutical composition thereof. The gastrodine compound is a crystal. The X-ray powder diffraction determines that the characteristic peaks are displayed when 2theta+ / -0.2 degree is 4.5 degrees, 5.7 degrees, 7.9 degrees, 10.3 degrees, 11.2 degrees, 13.0 degrees, 16.4 degrees, 19.6 degrees, 21.2 degrees, 22.7 degrees, 24.8 degrees, 26.7 degrees, 29.6 degrees, 34.1 degrees and 35.3 degrees. The gastrodine compound has very high stability, thereby greatly enhancing the medicine safety. The invention also relates to a pharmaceutical composition preparation containing the gastrodine compound. The composition preparation can be a freeze-dried powder injection, injection, tablet or capsule. The gastrodine freeze-dried powder injection, injection, tablet or capsule preparation provided by the invention has the advantages of simple prescription technique, obviously higher stability, and enhances the medicine safety and effectiveness.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a gastrodin compound and a pharmaceutical composition thereof. Background technique [0002] Gastrodin, the chemical name is 4-hydroxymethylbenzene-β-D-glucopyranoside hemihydrate. Gastrodin has good sedative and hypnotic effects, and can relieve neurasthenia, insomnia, and headache symptoms. The traditional Chinese medicine Gastrodia elata can treat dizziness, numbness, and convulsions. Clinical application: treatment of vertebral-basilar artery insufficiency; treatment of vestibular neuronitis; treatment of vertigo. [0003] The commonly used dosage forms of using gastrodin clinically are: injection, powder injection, tablet, capsule etc., because gastrodin stability is relatively poor, in order to solve this problem prior art, generally adopt a large amount of auxiliary materials, as: stabilizer, complexing agent, buffer salt to solve this problem, the addition of a large nu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07H15/203C07H1/06A61K31/7034A61P25/20A61P25/00
Inventor 李美林马虹
Owner 湖北美林药业有限公司
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