Gastrodin injection and preparation method and use thereof

The technology of gastrodin injection and gastrodin, which is applied in the field of chemical medicine, can solve problems such as pain, muscle necrosis, and mass, and achieve the effects of convenient clinical use, improved product quality, and high bioavailability.

Inactive Publication Date: 2019-07-02
王旭宁
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After intramuscular injection, it will play a role after being absorbed into the blood through the skin, and the onset of effect is slow; and the problem of intramuscular injection is pain at the injection site of the patient and adverse reactions such as local redness, congestion, lumps, and even muscle necrosis may occur after long-term injection; the raw materials used in production Due to the problem of the preparation process, there is a problem of low purity, and there are also certain potential safety hazards

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] A) Take fresh water for injection at 80°C, add gastrodin in a ratio of 1:4, stir well to dissolve completely, place it at room temperature, refrigerate at 10°C for 12 hours, ultrafilter with an ultrafilter with a molecular weight cut-off of less than 100,000, and then Ultrafiltration with an ultrafilter with a molecular weight cut-off of less than 5000 to obtain the gastrodin ultrafiltrate, which is sampled to detect the content.

[0037] B) Add 0.03% disodium oxalate tetraacetate in total weight to the ultrafiltrate, adjust the pH to 5.3 according to the content of gastrodin, and after the intermediate product is qualified, the liquid is filled in ampoules through terminal filtration In the process, use a water bath to sterilize, sterilize at 108° C. for 30 minutes, inspect with light, and the clarity is 98%, pack it, and obtain the finished product of gastrodin injection.

Embodiment 2

[0039] A) Take fresh water for injection at 90°C, add gastrodin in a ratio of 2:5, stir well to dissolve completely, place it at room temperature, refrigerate at 5°C for 24 hours, ultrafilter with an ultrafilter with a molecular weight cut-off of less than 100,000, and then Ultrafiltration with an ultrafilter with a molecular weight cut-off of less than 3000 to obtain the gastrodin ultrafiltrate, which is sampled to detect the content.

[0040] B) Add 0.04% disodium oxalate tetraacetate of total weight to the ultrafiltrate, adjust the pH to 5.9 according to the content of gastrodin, and after the intermediate product is qualified, the liquid is filled in ampoules through terminal filtration In the process, use steam sterilization, sterilize at 110° C. for 35 minutes, light inspection, the clarity is 99%, and pack to obtain the finished product of gastrodin injection.

Embodiment 3

[0042] A) Take fresh water for injection at 85°C, add gastrodin in a ratio of 1:1, stir well to dissolve completely, place it at room temperature, refrigerate at 0°C for 48 hours, ultrafilter with an ultrafilter with a molecular weight cut-off of less than 100,000, and then Ultrafiltration with an ultrafilter with a molecular weight cut-off of less than 5000 to obtain the gastrodin ultrafiltrate, which is sampled to detect the content.

[0043] B) Add 0.05% oxalate tetraacetic acid to the ultrafiltrate, adjust the pH to 7.0 according to the content of gastrodin, and after the intermediate product is qualified, the liquid is filtered and filled in an ampoule at a temperature of 108° C. Sterilize in a water bath for 30 minutes, inspect with light, and the clarity is 98%, and pack to obtain the finished product of gastrodin injection.

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Abstract

The present invention discloses a gastrodin injection, and at the same time also discloses a preparation method and a use thereof. The gastrodin injection comprises gastrodin, water for injection anda metal complexing agent. The gastrodin is subjected to water sedimentation, refrigeration, ultrafiltration and sterilization, ineffective ingredients are ensured to be completely removed, related substances in the preparation are reduced, the prepared preparation has good stability, the related substances and pyrogen items meet quality standards, a curative effect is stable, clarity is improved,and clinical experiments prove that gastrodin injection is capable of intravenous injection. The gastrodin injection is used for preparing drugs for treatments of neurasthenia, neurasthenia syndromesand traumatic brain syndromes, vertigo including Meniere's disease, drug vertigo, traumatic vertigo, sudden deafness, vestibular nerve cell inflammation, vertebral basilar artery insufficient blood supply, etc., neuralgia including trigeminal neuralgia, sciatica, occipital neuralgia, etc., and headache including vascular headache, migraine, neurasthenia, neurasthenia syndromes and other diseases.

Description

technical field [0001] The invention relates to a gastrodin injection, a preparation method and application thereof, and belongs to the field of chemical medicine. Background technique [0002] Gastrodin is the main active ingredient in Gastrodia elata BL., a perennial parasitic plant of Orchidaceae. Gastrodin, the chemical name is p-hydroxymethylphenyl-β-D-glucopyranoside (P-hydroxymethylPhenyl-β-D-glucopyranoside), white needle-like crystals, melting point 154°C-156°C, that is Gastrodia elata glycosides. [0003] Pharmacological experiments have shown that gastrodin can restore the imbalance between the excitation and inhibition of the cerebral cortex, and has central inhibitory effects such as sedation, sleep and analgesia. Acute toxicity experiments and subacute toxicity experiments show that gastrodin has no effect on hematopoietic system, liver, kidney function and blood lipid. [0004] At present, gastrodin is used as the main active ingredient in clinical applicat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7034A61K47/18A61P25/00A61P25/20A61P25/04A61P25/06A61P1/08
CPCA61K9/0019A61K9/08A61K31/7034A61K47/183
Inventor 王旭宁
Owner 王旭宁
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