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Gastrodin injection and preparation method thereof

A technology for gastrodin injection and injection, which can be applied in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc., which can solve injection pain or other adverse reactions and increase the cost of gastrodin injection. , the instability of gastrodin aqueous solution, etc., to achieve the effect of reducing unpredictable risks, good product stability, and reducing injection pain

Active Publication Date: 2010-01-13
HAINAN LEVTEC PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Due to the unstable gastrodin aqueous solution, a large amount of auxiliary materials such as stabilizers and metal ion complexing agents need to be added when gastrodin is prepared into injections, but the addition of a large number of auxiliary materials not only increases the cost of gastrodin injection, but also due to many The addition of such excipients leads to the increase of exogenous impurities in the injection, which is likely to cause injection pain or other adverse reactions during the use of the injection, which increases the risk of clinical unpredictability and is not conducive to the use of the injection.
In addition, the storage stability of the existing gastrodin injection needs to be further improved

Method used

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  • Gastrodin injection and preparation method thereof
  • Gastrodin injection and preparation method thereof
  • Gastrodin injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Embodiment 1 1000

[0024] Prescription: Gastrodin 100g

[0025] Acetic acid-sodium acetate buffer 15ml

[0026] Add water for injection to 1000ml

[0027]

[0028] Made 1000 pieces

[0029] Prepare an appropriate amount of acetic acid-sodium acetate buffer solution for later use. Take an appropriate amount of water for injection and put it into the concentrated preparation tank, add 100g of gastrodin, and stir until completely dissolved. Add the prepared acetic acid-sodium acetate buffer solution, stir and mix evenly. Weigh 0.2% of the liquid amount of activated carbon into the concentrated preparation tank, add water for injection to the full amount, stir for 20 minutes, then circulate and stir for 10 minutes, filter for decarbonization, and then filter and sterilize through a 0.22 μm microporous filter element. The fine filtrate was taken for intermediate detection. After qualified, potting, autoclaving at 121°C for 15 min...

Embodiment 2

[0030] Embodiment 2 1000

[0031] Prescription: Gastrodin 100g

[0032] Citric acid 0.15g

[0033] Disodium hydrogen phosphate 0.36g

[0034] Add water for injection to 1000ml

[0035]

[0036] Made 1000 pieces

[0037] First take an appropriate amount of water for injection and put it into the concentrated preparation tank, add 100g of gastrodin, and stir until it is completely dissolved. Weigh the prescribed amount of citric acid and disodium hydrogen phosphate and dissolve it in an appropriate amount of water for injection. After stirring to dissolve, add it to the concentrated preparation tank and stir evenly. Weigh 0.2% of the liquid amount of activated carbon and add it to the concentrated preparation tank, add water for injection to the full amount, stir for 40 minutes, then circulate and stir for 10 minutes, filter for decarbonization, and then filter and sterilize through a 0.22 μm microporous filter element. The fine filtrate was ta...

Embodiment 3

[0038] Embodiment 3 1000

[0039] Prescription: Gastrodin 100g

[0040] Disodium hydrogen phosphate-sodium dihydrogen phosphate buffer 10ml

[0041] Acetic acid-sodium acetate buffer 10ml

[0042] Add water for injection to 1000ml

[0043]

[0044] Made 1000 pieces

[0045] Prepare appropriate amount of disodium hydrogen phosphate-sodium dihydrogen phosphate buffer and acetic acid-sodium acetate buffer for later use. Take 100g of water for injection and put it into the concentrated preparation tank, add 100g of gastrodin, and stir until completely dissolved. Add the prepared disodium hydrogen phosphate-sodium dihydrogen phosphate buffer and acetic acid-sodium acetate buffer, stir and mix evenly. Weigh 0.2% of the liquid amount of activated carbon and add it to the concentrated preparation tank, add water for injection to the full amount, stir for 30 minutes, then circulate and stir for 15 minutes, filter for decarbonization,...

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Abstract

The invention discloses a gastrodin injection and a preparation method thereof. The gastrodin injection comprises gastrodin which is an active constituent, an accessory and water for injection. A prescription process is simplified through a large number of experiments, and the accessory only consists of buffer salt which has the effects of pH regulation and stabilization. The gastrodin injection does not contain organic solvents, auxiliary solvents, antioxidants and metal ion complexing agents, thereby improving the safety of clinical medicines and reducing the cost. Proved by pharmacological experiments, the gastrodin injection does not have anaphylaxis, irritant reactions and hemolytic reactions and can guarantee the medicine safety. The gastrodin injection has the advantage of solving the problems of reduced content and unstable pH value of the gastrodin injection in the process of storage, has simple prescription, good stability, low production cost, guarantees of medicine quality and safety and can be stored for two years at normal temperature.

Description

technical field [0001] The invention relates to a gastrodin injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Gastrodin is an effective monomer in the famous and precious Chinese medicinal material Gastrodia elata. It is used for neurasthenia, neurasthenia syndrome and angioneurotic headache (such as migraine, trigeminal neuralgia, occipital neuralgia, etc.) Syndrome, vertigo such as Meniere's disease, drug-induced vertigo, traumatic vertigo, vestibular neuronitis, vertebrobasilar insufficiency, etc. [0003] The chemical name of gastrodin is: 4-hydroxymethylbenzene-β-D-glucopyranoside hemihydrate, and its chemical structural formula is: [0004] [0005] Due to the unstable gastrodin aqueous solution, a large amount of auxiliary materials such as stabilizers and metal ion complexing agents need to be added when gastrodin is prepared into injections, but the addition of a large numbe...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7034A61K47/12A61K47/02A61P1/08A61P25/00A61P25/06A61P29/00
Inventor 黄飞龙娇张志宏邢贞凯
Owner HAINAN LEVTEC PHARMA
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