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Injection medicine composition of tetrandrine

A technology for tetrandrine and injection, which is applied in the field of medicine, can solve the problems such as no better solution, unqualified inspection items for visible foreign bodies, etc., and achieves the effect of facilitating clinical medication and promotion, and stabilizing the pH value of the medicinal solution.

Inactive Publication Date: 2018-03-02
CHENGDU XIANXIANXIAN 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 tetrandrine injection prepared by using the above-mentioned pH regulator is easy to precipitate fine white spots, white lumps, cloudy solution and other precipitates during long-term storage and winter low temperature conditions, resulting in the unqualified inspection items for visible foreign matter of the product
There is no better solution

Method used

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  • Injection medicine composition of tetrandrine
  • Injection medicine composition of tetrandrine
  • Injection medicine composition of tetrandrine

Examples

Experimental program
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Effect test

Embodiment 1

[0026] A method for preparing a pharmaceutical composition for injection that improves the stability of tetrandrine drug injection preparations, comprising the following steps: (1) weighing 0.1 g to 100 g of the raw material drug based on tetrandrine, 9.0 g of sodium sulfite, and phenylacetic acid 1mg~2.0g, sodium phenylacetate 1mg~2.0g; (2) Phenylacetic acid and sodium phenylacetate were prepared into 10%~20% solutions respectively for later 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...

Embodiment 2

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

[0032] (1) Weigh 0.1g-100g of the raw material medicine, 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] Tetrandrine Hydrochloride 20g

[0035] Phenylacet...

Embodiment 3

[0039] Comparative Test of Stability of Tetrandrine Sodium Sulfite Injection

[0040] The detection of visible foreign matter of the tetrandrine sodium sulfite 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 solution of tetrandrine is solved. Sodium sulfite injection is prone to problems such as small white spots, white lumps, and cloudy solution during storage. Utilize the tetrandrine sodium sulfite 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, respectively investigated at 25 ℃ for 24 months, 40 ℃ for 6 months , 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 ...

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Abstract

The invention discloses an injection medicine composition of tetrandrine. The injection medicine composition is characterized in that salt of tetrandrine is dissolved into injection water, and phenylacetic acid and / or sodium phenylacetate is used as a pH (potential of hydrogen) adjuster and is added to adjust the pH value of medicine liquid, so as to obtain the injection medicine composition; theusage amount of the phenylacetic acid and / or sodium phenylacetate 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; compared with the prior art, the content of degrading matters of the tetrandrine is greatly reduced; under the condition of avoiding using other cosolvents increasing the clinical application risk, the clarification degree of the tetrandrine injection liquid is improved, and especially the problems of small white spots, white blocks, and solution turbidity under the condition of longer storage time are solved when the tetrandrine injection liquid adopts the prior art product; after checking, the content of visible foreign matters in the product meets the requirement of medicine quality standard, and the injection medicine composition is suitable for clinical medicine application and popularization.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition for injection of tetrandrine. Background technique [0002] Tetrandrine, also known as tetrandrine, was once called tetrandrine and tetrandrine A. It is a bimolecular benzyl isoquinoline alkaloid with an oxygen bridge, and its molecular formula is C38H42N2O6. In 1932, Kondo Heizaburo first obtained it from the fallen arch root. Tetrandine is a needle-like crystal with a melting point of 217-218°C. It has analgesic and anti-inflammatory effects, the analgesic effect is 13% of that of morphine, and the anti-inflammatory effect is similar to that of cortisone. Tetrandrine has a good therapeutic effect on hypertension, especially for severe hypertension. Tetrandrine's quaternary ammonium salt (iodide) is called Hanjisong, which has the effect of relaxing muscles and was once used in the bed. [0003] Since tetrandrine has very poor solubi...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/12A61K31/4748A61P29/00A61P9/12A61P21/02
CPCA61K9/08A61K9/0019A61K31/4748A61K47/12
Inventor 付裕
Owner CHENGDU XIANXIANXIAN BIOTECH CO LTD
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