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Preparation method of injection medicine for improving stability of quercetin medicine injection preparation

An injection preparation, quercetin technology, applied in the field of medicine, can solve the problems of inconvenient clinical application and promotion, high risk of clinical application of injections, easy rancidity, etc. Effect of reducing corticosteroid-degrading substances

Inactive Publication Date: 2016-09-28
CHENGDU YICHUANGSI BIOLOGICAL SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because polysorbate 80 has hemolysis and hypotensive effects, and is prone to rancidity during storage and high-temperature sterilization, the risk of clinical application of injections containing polysorbate 80 is relatively high, which brings inconvenience to clinical medication and promotion.

Method used

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  • Preparation method of injection medicine for improving stability of quercetin medicine injection preparation
  • Preparation method of injection medicine for improving stability of quercetin medicine injection preparation
  • Preparation method of injection medicine for improving stability of quercetin medicine injection preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A method for preparing a pharmaceutical composition for injection that improves the stability of quercetin drug injection preparations, comprising the following steps: (1) weighing 0.1 g to 100 g of the raw material drug calculated as quercetin, 9.0 g of sodium chloride, Citric acid 1mg~2.0g, sodium citrate 1mg~2.0g; (2) Citric acid and sodium citrate were prepared into 10%~20% solutions respectively for later use. (3) Add 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) Adjust the pH value of the filtrate to 3.0-7.0 with citric acid or sodium citrate solution, add water for injection below 40°C to 1000ml; (5) filter the liquid medicine until it is clear, fill it, and sterilize it.

[0026] The specific components and contents thereof of the present embodiment are as follows:

[0027] Quercetin Hydrochloride 0.8g

[0028] Sodium chloride 9.0g

[0029] Cit...

Embodiment 2

[0033] Alternatively, the above pharmaceutical composition for injection that improves the stability of quercetin drug injection preparations is prepared according to the following steps:

[0034] (1) Weigh 0.1g-100g of the raw material medicine, 1mg-2.0g of citric acid and 1mg-2.0g of sodium citrate; (2) prepare 100g of citric acid and sodium citrate respectively % to 20% solution, for later use. (3) Add 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) Adjust the pH value of the filtrate to 3.0-7.0 with citric acid or sodium citrate solution, add water for injection below 40°C to 1000ml; (5) filter the liquid medicine until clear, fill it, and sterilize it.

[0035] The specific composition and content of each component of the present embodiment are as follows:

[0036] Quercetin Hydrochloride 20g

[0037] Citric acid 1.0g

[0038] Sodium citrate 2.0g

[0039...

Embodiment 3

[0041] Comparative Test of Stability of Quercetin Sodium Chloride Injection

[0042] The detection of visible foreign matter in the quercetin sodium chloride injection prepared by the present invention complies with the provisions of the drug quality standard, and the solution stability is very good. In the case of avoiding the use of other co-solvents that increase the risk of clinical application, it solves the problem of quercetin and sodium chloride injection. Small white spots, white lumps, and turbidity of the solution are prone to appear during the storage of Dermatol Sodium Chloride Injection. Utilize the quercetin sodium chloride injection that the present invention makes according to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix Ⅺ XC drug preparation stability test guiding principle, have investigated respectively place 24 months at 25 ℃, 6 months at 40 ℃. months, 10 days at 60°C, and 20 days at 0-5°C for 20 days. As a result, the q...

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Abstract

The invention discloses an injection medicine composition for improving the stability of a quercetin medicine injection preparation, and a preparation method thereof. The injection medicine composition is an injection medicine composition mainly prepared by dissolving salt of quercetin into injection water and adding citric acid and / or sodium citrate as pH regulators to regulate the pH value of medicine liquid. The consumption of the citric acid and / or sodium citrate is 0.1mg to 200.0mg / 100ml. The injection medicine composition has the advantages that the pH value of the injection liquid is more stable; the quercetin degradation substances are greatly reduced through being compared with that in the prior art; under the condition of not using other solutizers increasing the clinic application risks, the clarity of the quercetin injection liquid is improved; the problems of small white points, white blocks and solution turbidity of a product of the quercetin injection liquid in the prior art under the condition of long storage time are particularly solved; the visible foreign matter inspection of the product is enabled to conform to the specification of the medicine quality standard; the clinic medication and popularization are convenient.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a method for preparing injection medicines for improving the stability of quercetin medicine injection preparations. Background technique [0002] Quercetin is soluble in glacial acetic acid, the alkaline aqueous solution is yellow, almost insoluble in water, and the ethanol solution tastes very bitter. It can be used as a medicine, which has good expectorant and cough-relieving effects, and has a certain anti-asthmatic effect. In addition, it has the effects of lowering blood pressure, enhancing capillary resistance, reducing capillary fragility, lowering blood lipids, expanding coronary arteries, and increasing coronary blood flow. For the treatment of chronic bronchitis. It also has an adjuvant therapeutic effect on patients with coronary heart disease and hypertension. [0003] Since quercetin has very poor solubility in aqueous solution, it is made into quer...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/352A61K47/12A61P11/10A61P11/14A61P11/06A61P9/12A61P3/06A61P11/00A61P9/10
CPCA61K9/08A61K9/0019A61K31/352A61K47/12
Inventor 周洁
Owner CHENGDU YICHUANGSI BIOLOGICAL SCI & TECH
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