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Gingerol pharmaceutical composition for injection

A technology for gingerol and injection, which is applied in the field of medicine, can solve the problems of no better solution, unqualified inspection items of visible foreign matter, easy precipitation of small white spots, etc., and achieves the convenience of clinical medication and promotion, pH The effect of stabilizing and reducing the degradation substances of gingerol

Inactive Publication Date: 2018-05-01
成都源来来科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But when preparing the above injection, the pH value of the medicinal liquid must be adjusted to a certain range suitable for human injection administration. The pH value regulators used in current literature reports are sodium hydroxide solution or use hydrochloric acid solution and phosphoric acid solution, but Gingerol injection prepared with the above-mentioned pH value regulator is prone to precipitate fine white spots, white lumps, cloudy solution and other precipitates during long-term storage and winter low temperature conditions, resulting in the failure of the visible foreign matter inspection item of the product
There is no better solution

Method used

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  • Gingerol pharmaceutical composition for injection
  • Gingerol pharmaceutical composition for injection
  • Gingerol pharmaceutical composition for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] A method for preparing a pharmaceutical composition for injection that improves the stability of gingerol drug injection preparations, comprising the following steps: (1) weighing 0.1 g to 100 g of raw materials calculated as gingerol, and 9.0 g of sodium thiosulfate , 1 mg-2.0 g of phenylacetic acid, 1 mg-2.0 g of sodium phenylacetate; (2) 10%-20% solutions of phenylacetic acid and sodium phenylacetate were prepared for future use. (3) Add to 500ml of water for injection below 40°C, stir until completely dissolved, then add 0.02% (g / ml) activated carbon, stir for 15 minutes, filter and decarburize. (4) Use phenylacetic acid or sodium phenylacetic acid solution to adjust the pH of the filtrate to 3.0-7.0, add water for injection below 40°C to 1000ml; (5) filter the medicinal solution until it is clear, fill it, and sterilize it.

[0027] The specific components and contents thereof of the present embodiment are as follows:

[0028]

[0029] Phenylacetic acid and sod...

Embodiment 2

[0031] Or, the above-mentioned pharmaceutical composition for injection that improves the stability of the gingerol drug injection preparation is prepared according to the following steps:

[0032] (1) Weigh 0.1g-100g of raw materials calculated as gingerol, 1mg-2.0g of phenylacetic acid, and 1mg-2.0g of sodium phenylacetate; (2) prepare 10%-20% of phenylacetic acid and sodium phenylacetate respectively solution, set aside. (3) Add to 500ml of water for injection below 40°C, stir until completely dissolved, then add 0.02% (g / ml) activated carbon, stir for 15 minutes, filter and decarburize. (4) Use phenylacetic acid or sodium phenylacetic acid solution to adjust the pH of the filtrate to 3.0-7.0, add water for injection below 40°C to 1000ml; (5) filter the medicinal solution until it is clear, fill it, and sterilize it.

[0033] The specific components and contents thereof of the present embodiment are as follows:

[0034] Gingerol Hydrochloride 20g

[0035] Phenylacetic ac...

Embodiment 3

[0039] Comparative Test of Stability of Gingerol Sodium Thiosulfate Injection

[0040] The detection of visible foreign matter in the gingerol sodium thiosulfate injection prepared by the present invention complies with the provisions of the drug quality standard, and the stability of the solution is very good. In the case of avoiding the use of other co-solvents that increase the risk of clinical application, the problem is solved. Gingerol sodium thiosulfate injection is prone to problems such as small white spots, white lumps, and cloudy solution during storage. Gingerol Sodium Thiosulfate Injection prepared by the present invention was investigated respectively when placed at 25°C for 24 months and at 40°C according to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix XIXC drug preparation stability test guidelines. Drug stability after 6 months, 10 days at 60°C, and 20 days at 0-5°C low temperature. The result is that the product quality is ...

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Abstract

The invention discloses a gingerol pharmaceutical composition for injection. The pharmaceutical composition for injection is prepared mainly by the steps of dissolving salt of gingerol into water forinjection, adding phenylacetic acid and / or sodium phenylacetate as pH regulator(s) for regulating the pH value of liquid medicine, wherein the dosage of the phenylacetic acid and / or the sodium phenylacetate is 0.1-200.0mg / 100ml. The gingerol pharmaceutical composition can enable the pH value of injection to be more stable, and greatly reduces gingerol degradation substances compared with the priorart; under the premise of avoiding the use of other co-solvents which increase the risk of clinical application, the clarity of the gingerol injection is improved, and the problems that the ginger injection prepared from the products in the prior art has small white spots, white blocks and turbid solution after being stored for a long time can be particularly solved, and the visible foreign matter examination of the product is enabled to be in compliance with the provisions of the drug quality standards; therefore, the gingerol pharmaceutical composition for injection is convenient for clinical medication and promotion.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a pharmaceutical composition of gingerol for injection. Background technique [0002] Gingerol is a mixture extracted from ginger that contains gingerol, gingerol and other spicy substances related to ginger, which has the effect of resisting lipofuscin. Used to help prevent or treat nausea and vomiting caused by motion sickness, pregnancy, etc. It has the effects of invigorating the stomach and anti-gastric ulcer, promoting gallbladder, protecting the liver, strengthening the heart, inhibiting platelet aggregation, anti-dizziness, anti-tumor, central inhibition, enhancing immunity, antibacterial, insecticidal, anti-inflammatory, and has a strong antioxidant capacity . [0003] Since gingerol has very poor solubility in aqueous solution, it is made into gingerol hydrochloride or gingerol phosphate to increase its water solubility. Currently commercially available...

Claims

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Application Information

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IPC IPC(8): A61K36/9068A61K47/12A61K9/08A61P1/08A61P1/04A61P1/16A61P7/02A61P35/00A61P25/00A61P37/04A61P31/04A61P33/00A61P29/00A61P39/06
CPCA61K36/9068A61K9/0019A61K9/08A61K47/12
Inventor 杨利华
Owner 成都源来来科技有限公司
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