Pharmaceutical composition of oil of zedoary turmeric for injection

A technology for zedoary turmeric oil and injection, which is applied in the field of medicine, can solve the problems of unqualified inspection items for visible foreign bodies, no better solution, easy precipitation of small white spots, etc., so as to facilitate clinical drug use and promotion, and achieve stable pH value. Effect

Inactive Publication Date: 2018-03-06
CHENGDU SHENGSHI GUANGHUA BIOTECH CO LTD
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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 The zedoary oil injection prepared with the above-mentioned pH value regulator is easy to precipitate fine white spots, white lumps, solution turbidity and other precipitates during long-term storage and winter low temperature conditions, resulting in unqualified inspection items for visible foreign matter of the product
There is no better solution

Method used

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  • Pharmaceutical composition of oil of zedoary turmeric for injection
  • Pharmaceutical composition of oil of zedoary turmeric for injection
  • Pharmaceutical composition of oil of zedoary turmeric 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 zedoary oil drug injection preparations, comprising the following steps: (1) weighing 0.1 g to 100 g of raw materials calculated as zedoary oil, 9.0 g of sodium pyrosulfite, and 1 mg to 1 mg of formic acid. 2.0g, sodium formate 1mg ~ 2.0g; (2) Formic acid and sodium formate were prepared into 10% ~ 20% solutions respectively, and 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 formic acid or sodium formate solution to adjust the pH value 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] Formic acid and sodium formate w...

Embodiment 2

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

[0032] (1) Weigh 0.1g-100g of raw materials calculated as zedoary oil, 1mg-2.0g of formic acid, and 1mg-2.0g of sodium formate; (2) prepare 10%-20% solutions of formic acid and sodium formate respectively, and 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 formic acid or sodium formate solution to adjust the pH value 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] Curcuma oil hydrochloride 20g

[0035] Formic acid 1.0...

Embodiment 3

[0039] Comparative Test of Stability of Zedoary Oil Sodium Pyrosulfite Injection

[0040] The detection of visible foreign matter of zedoary oil sodium pyrosulfite injection prepared by the present invention complies with the provisions of the drug quality standard, and the solution stability is very good. Under the condition of avoiding the use of other co-solvents that increase the risk of clinical application, the zedoary oil coke is solved. Sodium sulfite injection is prone to problems such as small white spots, white lumps, and cloudy solution during storage. Utilize the curcuma oil sodium pyrosulfite injection that the present invention makes according to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix XIXC drug preparation stability test guiding principle, respectively investigated and placed 24 months at 25 ℃, 6 months at 40 ℃ , Placed at 60°C for 10 days, and placed at 0-5°C for 20 days for drug stability. As a result, the product qual...

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Abstract

The invention discloses a pharmaceutical composition of oil of zedoary turmeric for injection. The pharmaceutical composition is primarily prepared by dissolving salt of oil of zedoary turmeric in water for injection and adding formic acid and / or sodium formate as a pH adjustor to adjust the pH value of medicinal liquid to prepare the pharmaceutical composition for injection, wherein the dosage offormic acid and / or sodium formate is 0.1-200.0mg / 100ml. The pH value of the injection liquid is more stable. Degrading matters for oil of zedoary turmeric are reduced greatly compared with those in the prior art. On the premise of not using other cosolvents which increase clinical application risks, the clarity of the injection liquid of oil of zedoary turmeric is improved, and in particular, theproblem that small particles, white blocks and turbid solution of injection liquid of oil of zedoary turmeric in the prior art stored for a relatively long time is solved, visible foreign matter examination of the pharmaceutical composition meets the drug quality standard, and clinical medication and popularization are facilitated.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a medicinal composition of zedoary oil for injection. Background technique [0002] Curcuma oil is used for colds, cholera vomiting and diarrhea, summer heat syndrome, stroke, phlegm unconsciousness, loss of breath, head tingling, wind-fire toothache, bronchial asthma and various coughs, cold and heat stomach pain, back and limb pain, itching Syndrome, scabies, unknown swollen poison, bruises, burns, snakes, scorpions, pikes, centipedes, hematemesis, insomnia, traumatic bleeding. [0003] Because zedoary oil has very poor solubility in aqueous solution, it is made into zedoary oil hydrochloride or zedoary oil phosphate to increase its water solubility. The currently commercially available Zedoary Oil Injection mainly includes small-volume injections of Zedoary Oil Hydrochloride and Zedoary Oil Phosphate, as well as adding glucose or sodium pyrosulfite as an antioxi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/9066A61K9/08A61K47/12A61P17/02A61P29/00
CPCA61K36/9066A61K9/0019A61K9/08A61K47/12
Inventor 陈通
Owner CHENGDU SHENGSHI GUANGHUA BIOTECH CO LTD
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