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Preparation method of tetrandrine injection preparation pharmaceutical composition

A technology for tetrandrine and injection preparations, applied in the field of medicine, can solve the problems such as no better solution, unqualified inspection items for visible foreign bodies, etc., and achieve the effects of facilitating clinical medication and popularization, and stable pH value of the medicinal solution.

Inactive Publication Date: 2018-03-23
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 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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  • Preparation method of tetrandrine injection preparation pharmaceutical composition
  • Preparation method of tetrandrine injection preparation pharmaceutical composition
  • Preparation method of tetrandrine injection preparation pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] 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, and 9.0 g of sodium dihydrogen phosphate , salicylic acid 1mg~2.0g, sodium salicylate 1mg~2.0g; (2) salicylic acid and sodium salicylate 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) Adjust the pH value of the filtrate to 3.0-7.0 with salicylic acid or sodium salicylate solution, add water for injection below 40°C to 1000ml; (5) filter the liquid medicine until it is clear, fill it, and sterilize it.

[0021] The specific components and contents thereof of the present embodiment are as follows:

[0022]

[0023] Salicylic acid and sodi...

Embodiment 2

[0025] 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:

[0026] (1) Weigh 0.1g-100g of the raw material medicine, 1mg-2.0g of salicylic acid and 1mg-2.0g of sodium salicylate; % to 20% solution 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) Adjust the pH value of the filtrate to 3.0-7.0 with salicylic acid or sodium salicylate solution, add water for injection below 40°C to 1000ml; (5) filter the liquid medicine until it is clear, fill it, and sterilize it.

[0027] The specific components and contents thereof of the present embodiment are as follows:

[0028] Tetrandrine Hydrochloride 20g

[0029] Salicylic acid 1.0g

[0030] Sodium salicylate 2.0g

[0031] Salicylic acid and sodium sal...

Embodiment 3

[0033] Comparative Test on Stability of Tetrandrine Sodium Dihydrogen Phosphate Injection

[0034] The detection of visible foreign matter of the tetrandrine sodium dihydrogen phosphate 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, the solution is solved. Tetrandrine sodium dihydrogen phosphate injection is prone to problems such as small white spots, white lumps, and cloudy solution during storage. Utilize the tetrandrine sodium dihydrogen phosphate 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 guideline requirements, investigated respectively placed at 25 ℃ for 24 months, 40 ℃ placed Drug stability after 6 months, 10 days at 60°C, and 20 days at 0-5°C l...

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Abstract

The invention discloses a preparation method of a tetrandrine injection preparation pharmaceutical composition. The pharmaceutical composition for injection is prepared by dissolving tetrandrine saltsinto water for injection, and then adding salicylic acid and / or sodium salicylate as a pH modifier to regulate the pH value of the liquid medicine. The usage of salicylic acid and / or sodium salicylate ranges from 0.1 mg to 200.0mg / 100ml. According to the preparation method, the pH value of the injection solution is much stable; the degradable substance of tetrandrine is much lower than that of the prior art; on the premise of not using other co-solvents which could increase clinical application risks, clarity of the tetrandrine injection solution is improved, and the problems of white dots, white flakes and turbidity of the the tetrandrine injection in long-term preservation by the prior art are solved, results of test on visible foreign matters of the product accord with drug standards, and clinical application and promotion of the product is facilitated.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of a tetrandrine injection pharmaceutical composition. 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...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/12A61K31/4748A61P29/00A61P9/12
CPCA61K9/08A61K9/0019A61K31/4748A61K47/12
Inventor 陈通
Owner CHENGDU SHENGSHI GUANGHUA BIOTECH CO LTD
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