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
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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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