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Preparation method of composition capable of improving stability of quinidine sulfate injection preparation

A technology of quinidine sulfate and injection preparation, which is applied in the field of medicine, can solve the problems of easy rancidity, high risk of clinical application of injection, inconvenient clinical medication and promotion, etc. Reduced effect of degrading substances

Inactive Publication Date: 2016-12-07
成都佳迪璐莎生物科技有限公司
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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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] The preparation method of the composition for improving the stability of quinidine sulfate injection preparations comprises the following steps: (1) Weighing 25 g of the raw material medicine calculated from the quinidine sulfate extract, 7.0 g of sodium chloride, 2 g of malic acid, and 2 g of malic acid Sodium 4mg; (2) Malic acid and sodium malate were prepared into 10%-20% solutions respectively for later use; (3) Added to 500ml of water for injection below 40°C, stirred until completely dissolved, then added 0.02% (g / ml) of activated carbon, stirred for 15 minutes, and decarbonized by filtration; (4) The filtrate was adjusted to a pH of 3.0-7.0 with malic acid or sodium malate solution, and water for injection below 40°C was added to 1000ml; (5) The liquid was filtered to Clarify, fill, sterilize, and get ready.

[0020] The specific components and contents thereof of the present embodiment are as follows:

[0021] Quinidine Sulfate Extract 25g

[0022] Sodium chl...

Embodiment 2

[0027] Another embodiment of this example, as shown below, the above-mentioned pharmaceutical composition for injection that improves the stability of the quinidine sulfate pharmaceutical injection preparation is prepared according to the following steps:

[0028] (1) Weigh 70g of the raw material medicine calculated as quinidine sulfate, 3g of malic acid, and 6g of sodium malate; (2) Prepare 10% to 20% solutions of malic acid and sodium malate respectively for use; (3) Add 500ml of water for injection below 40°C, stir until completely dissolved, add 0.15% (g / ml) activated carbon, stir for 15 minutes, filter and decarburize; (4) Use malic acid or sodium malate solution to adjust the pH value of the filtrate If it is 4.0-6.0, add water for injection below 40°C to 1000ml; (5) filter the liquid medicine until it is clear, fill it, and sterilize it.

[0029] The specific components and contents thereof of the present embodiment are as follows:

[0030] Quinidine Sulfate Extract 7...

Embodiment 3

[0035] Comparative Test of Stability of Quinidine Sulfate Injection

[0036] The detection of visible foreign matter of quinidine sulfate injection prepared by the present invention complies with the provisions of drug quality standards, 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, it solves the problem of quinidine sulfate injection. Small white spots, white lumps, and turbidity of the solution are prone to appear during storage. Utilize the quinidine sulfate injection prepared by the present invention according to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix Ⅺ XC drug preparation stability test guiding principle, investigated respectively 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 quality is stable under the above test conditions, a...

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Abstract

The invention discloses a preparation method of a composition capable of improving the stability of a quinidine sulfate injection preparation. The preparation method comprises the following steps: (1) weighing quinidine sulfate, malic acid and / or sodium malate; (2) respectively preparing a malic acid solution and a sodium malate solution; (3) adding the quinidine sulfate into 50 ml of injection water with the temperature of 30 to 40 DEG C, stirring until the quinidine sulfate is completely dissolved, adding active carbon and then stirring, and filtering to remove the carbon; (4) adjusting the pH value of obtained filtrate obtained to 4.0 to 6.0 by using the prepared malic acid solution and / or the prepared sodium malate solution, and adding the injection water to 1,000 ml; (5) filtering the solution until the solution is clarified, and filling and sterilizing to obtain the composition. The preparation method can enable the pH value of the injection preparation to be more stable; compared with the prior art, the preparation method has the advantage that the quantity of quinidine sulfate degradation materials is greatly reduced; under a condition that the use of other cosolvents which may increase the clinical application risk is avoided, the clarity of the quinidine sulfate injection preparation is improved, the inspection of visible foreign matters of a product can meet the provisions of the drug standard, and clinical drug administration and popularization are facilitated.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a preparation method of a composition for improving the stability of quinidine sulfate injection preparations. Background technique [0002] Quinidine sulfate is mainly used for paroxysmal tachycardia, atrial fibrillation, and premature beats; prevention of ventricular tachycardia and atrioventricular nodal reentrant tachycardia; and prevention of symptomatic supraventricular and ventricular premature beats . [0003] Because quinidine sulfate has very poor solubility in aqueous solution, it is made into quinidine sulfate hydrochloride or quinidine sulfate phosphate to increase its water solubility. Currently commercially available quinidine sulfate injections mainly include small volume injections of quinidine sulfate hydrochloride and quinidine sulfate phosphate, and adding glucose or sodium chloride as an infiltration solution in the quinidine sulfate extract so...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/12A61K31/4709A61P9/06
CPCA61K9/08A61K9/0019A61K31/4709A61K47/12
Inventor 李云娟
Owner 成都佳迪璐莎生物科技有限公司
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