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Pharmaceutical composition for injection for improving stability of illicium henryi medication injection preparation

An injection preparation and technology of red fennel, applied in the field of medicine, can solve the problems of inconvenient clinical medication and promotion, easy rancidity, high risk of clinical application of injections, etc., and achieve the effects of convenient clinical medication and promotion, stable pH value, and reduced degradation substances

Inactive Publication Date: 2016-11-23
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

[0025] A method for preparing a pharmaceutical composition for injection that improves the stability of red fennel drug injection preparations, comprising the following steps: (1) Weighing 25 g of raw materials calculated from red fennel extract, 7.0 g of sodium chloride, and 2 g of caffeic acid , sodium caffeate 4mg; (2) caffeic acid and sodium caffeate were prepared into 10% to 20% solutions respectively, and used for later use; (3) added to 500ml of water for injection below 40°C, stirred until completely dissolved, and then added 0.02% (g / ml) of activated carbon, stirred for 15 minutes, and decarburized by filtration; (4) The filtrate was adjusted to a pH of 3.0-7.0 with caffeic acid or sodium caffeate solution, and water for injection below 40°C was added to 1000ml; (5) The liquid is filtered until clarified, filled, sterilized, and obtained.

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

[0027] Red fennel extract 25g

...

Embodiment 2

[0033] Another embodiment of this example, as shown below, the above-mentioned injection pharmaceutical composition for improving the stability of red fennel drug injection preparations is prepared according to the following steps:

[0034] (1) Weigh 70g of the raw material medicine calculated from red fennel, 3g of caffeic acid, and 6g of sodium caffeate; (2) prepare 10% to 20% solutions of caffeic acid and sodium caffeate for later use; (3) add 40 Add 0.15% (g / ml) activated carbon to 500ml of water for injection below ℃, stir until it is completely dissolved, add 0.15% (g / ml) activated carbon, stir for 15 minutes, filter and decarburize; (4) Use caffeic acid or sodium caffeate solution to adjust the pH value of the filtrate to 4.0 ~6.0, add water for injection below 40°C to 1000ml; (5) filter the liquid medicine until clarified, fill it, sterilize it, and get it.

[0035] The specific components and contents thereof of the present embodiment are as follows:

[0036] Red fen...

Embodiment 3

[0041] Comparative Test of Stability of Red Fennel Injection

[0042] The detection of visible foreign matter of the red fennel 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 red fennel injection has been solved. Problems such as small white spots, white lumps, and cloudy solution are prone to appear during storage. Utilize the red fennel injection prepared by the present invention according to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix Ⅺ Ⅹ C drug preparation stability test guidelines, investigated respectively placed at 25 ℃ for 24 months, 40 ℃ for 6 months, 60 ℃ for 10 days, and 0-5 ℃ for 20 days for drug stability. As a result, the quality of the product is stable under the above test conditions, and all test indicators are in line...

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PUM

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Abstract

The invention discloses a pharmaceutical composition for injection for improving stability of an illicium henryi medication injection preparation. The pharmaceutical composition for injection is mainly prepared by dissolving extracting solution of illicium henryi in water for injection, adding caffeic acid and / or sodium caffeate to serve as a pH regulator for regulating the pH value of the liquid medicine, wherein the amount of the caffeic acid and / or sodium caffeate is 1-5g / 100ml. According to the invention, the pH value of the injection can be stable, illicium henryi degradable substances are greatly reduced compared with that in the prior art, the clarity of the illicium henryi injection is improved under the condition that other cosolvents capable of increasing clinical application risk are not used, particularly the problems that the illicium henryi injection has small white spots and white blocks and turbid in solution when stored for a long time by adopting the products in the prior art are solved, inspection of visible foreign matters in the product can accord with regulations of drug standards, and the pharmaceutical composition is convenient for clinical medication and popularization.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a pharmaceutical composition for injection that improves the stability of red fennel drug injection preparations. Background technique [0002] Red Fennel Injection, reduces swelling, dissipates blood stasis, promotes blood circulation and relieves pain. For lumbar muscle strain, joint or muscle ligament injury and rheumatic pain. [0003] Because red fennel has very poor solubility in aqueous solution, it is made into red fennel hydrochloride or red fennel phosphate to increase its water solubility. Currently commercially available red fennel injections mainly include small-volume injections of red fennel hydrochloride and red fennel phosphate, and adding glucose or sodium chloride to red fennel hydrochloride and red fennel phosphate solutions as osmotic pressure regulators Large-volume injections made of medicaments. But when preparing the above injection, the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/57A61K9/08A61K47/12A61P19/02A61P19/04A61P21/00A61P29/00
CPCA61K36/57A61K9/0019A61K9/08A61K47/12
Inventor 李云娟
Owner 成都佳迪璐莎生物科技有限公司
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