Injectio of gastrodine, its preparing process and usage

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

Inactive Publication Date: 2005-07-06
巴里莫尔制药(通化)有限公司
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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

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 a 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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PUM

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Abstract

The invention provides a gastrodine injection, which comprises the forms of gastrodine water for injection and metal chelating agent, the invention also discloses its preparation and use. Wherein the preparation comprises depositing gastrodine with water, cold storing, ultrafiltration technology processing, and sterilizing. The injection can be used for treating brain trauma, megrims, nerve pain, cephalodynia and neurasthenia.

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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IPC IPC(8): A61K9/08A61K31/7034A61P25/00
Inventor 郭智华
Owner 巴里莫尔制药(通化)有限公司
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