Small volume intravenous injection of gastrodine and its prepn. method

A technology for gastrodin and injection, which is applied in the field of gastrodin intravenous small-volume injection and preparation thereof, can solve the problems of undisclosed content of auxiliary materials, undisclosed preparation method, etc., and achieves the effects of less adverse reaction, rapid curative effect and cost saving.

Inactive Publication Date: 2006-03-29
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

The content of the corresponding auxiliary materials is not disclosed in the above-mentioned patent specification, and the specific preparation method is not disclosed in the examples

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036]A) Take 300ml of fresh water for injection at 80°C, add 100g of gastrodin, 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 filter with a molecular weight cut-off The ultrafilter below 5000 is ultrafiltered to obtain the gastrodin ultrafiltrate, and the content is tested by sampling.

[0037] B) add 0.03% disodium ethylenediamine tetraacetate of total weight in the ultrafiltrate, adjust pH5.3, add water for injection and make it into 1000ml, after intermediate product inspection is qualified, obtain the product that contains 100mg gastrodin in every 1ml Intravenous small volume injection. Fill the medicinal liquid into ampoules through terminal filtration, each can hold 1ml, 2ml, 5ml, etc., use water bath to sterilize, sterilize at 108°C for 30 minutes, light inspection, the clarity is 98%, pack, and get Gastrodin small-volume i...

Embodiment 2

[0039] A) Take 500ml of fresh water for injection at 90°C, add 200g of gastrodin, 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 filter with a molecular weight cut-off The ultrafilter below 3000 is ultrafiltered to obtain the gastrodin ultrafiltrate, and the content is tested by sampling.

[0040] B) add 0.04% edetate disodium of total weight in the ultrafiltrate, adjust pH5.9, add water for injection and make it into 1000ml, after intermediate product inspection is qualified, obtain the product that contains 200mg gastrodin in every 1ml Intravenous small volume injection. Fill the medicinal liquid into ampoules through terminal filtration, each can hold 1ml, 2ml, 5ml, etc., use steam to sterilize, sterilize at 110°C for 35 minutes, check with light, the clarity is 99%, pack, and get Gastrodin small-volume intravenous injection finis...

Embodiment 3

[0042] A) Take 100ml of fresh water for injection at 85°C, add 10g of gastrodin, 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 filter with a molecular weight cut-off The ultrafilter below 5000 is ultrafiltered to obtain the gastrodin ultrafiltrate, and the content is tested by sampling.

[0043] B) add 0.05% ethylenediaminetetraacetic acid in the ultrafiltrate, adjust pH7.0, add water for injection and make it into 1000ml, after intermediate product inspection is qualified, promptly get the intravenous small volume injection that contains 10mg gastrodin in every 1ml . Fill the medicinal liquid into ampoules through terminal filtration, each can hold 1ml, 2ml, 5ml, etc., sterilize in a water bath at 108°C for 30 minutes, check with light, the clarity is 98%, and pack it to obtain gastrodin intravenous small volume Injection finished ...

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Abstract

A low-capacity intravenous injection of gastrodine for treating neurasthenia, neurasthenia syndrome, cerebral trauma syndrome, dizziness, Meniere's disease, reuralgia, headache, etc is prepared from gastrodine, the water for injection and metallic chelating agent. Its preparing process is also disclosed.

Description

【Technical field】 [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to gastrodin small-capacity intravenous injection and a preparation method thereof. 【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 mai...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7034A61K9/08A61P25/20A61P25/04
Inventor 郭智华
Owner 巴里莫尔制药(通化)有限公司
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