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Preparation method of berberine injection preparation pharmaceutical composition

An injection preparation and technology of berberine, applied in the field of medicine, can solve the problems of high risk of clinical application of injections, easy rancidity, inconvenient clinical use and promotion, etc., to achieve convenient clinical use and promotion, stable pH value of liquid medicine, berberine The effect of reducing degraded substances

Inactive Publication Date: 2017-01-25
CHENGDU XIANXIANXIAN BIOTECH CO LTD
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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 berberine injection preparation pharmaceutical composition
  • Preparation method of berberine injection preparation pharmaceutical composition
  • Preparation method of berberine injection preparation pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] A method for preparing a berberine injection pharmaceutical composition, comprising the following steps: (1) weighing 0.1 g to 100 g of raw materials calculated as berberine, 9.0 g of sodium chloride, 1 mg to 2.0 g of fruit acid, and 1 mg to 2.0 g of fruit acid Sodium 1mg ~ 2.0g; (2) Fruit acid and sodium fruit acid were prepared into 10% ~ 20% solution 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 fruit acid or sodium fruit acid 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] Fruit acid and sodium fruit acid are respectively prepared into 10%-20% solutions for late...

Embodiment 2

[0025] Or, the preparation method of the above-mentioned a kind of berberine injection pharmaceutical composition is prepared according to the following steps:

[0026] (1) Weigh 0.1g-100g of raw material medicine, 0.1g-100g of berberine, 1mg-2.0g of fruit acid, 1mg-2.0g of sodium fruit acid; 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) Adjust the pH value of the filtrate to 3.0-7.0 with fruit acid or sodium fruit acid 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] Berberine Hydrochloride 20g

[0029] AHA 1.0g

[0030] Sodium Hydroxide 2.0g

[0031] Fruit acid and sodium fruit acid are respectively prepared into 10%-20% solutions for lat...

Embodiment 3

[0033] Comparative Test of Stability of Berberine Sodium Chloride Injection

[0034] The detection of visible foreign matter of the berberine sodium chloride injection prepared by the present invention complies with the provisions of the drug quality standard, and the solution stability is very good. Under the condition of avoiding the use of other co-solvents that increase the risk of clinical application, the solution of berberine Sodium chloride injection is prone to problems such as small white spots, white lumps, and cloudy solution during storage. Utilize the prepared berberine sodium chloride injection of the present invention according to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix Ⅺ XC pharmaceutical preparations stability test guiding principle, have investigated and placed 24 months at 25 ℃, 6 at 40 ℃ respectively. The stability of the drug can be obtained by placing it at 60°C for 10 days, and at 0-5°C for 20 days. The results s...

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Abstract

The invention discloses a method for preparing a berberine injection pharmaceutical composition. The injection pharmaceutical composition mainly consists of dissolving berberine salt in water for injection, adding fruit acid and / or sodium fruit acid as a pH regulator to adjust the liquid The pharmaceutical composition for injection prepared by the pH value, the dosage of the fruit acid and / or sodium fruit acid is 0.1mg-200.0mg / 100ml. The invention can make the pH value of the injection more stable, greatly reduce the degradation substances of berberine compared with the prior art, and improve the clarity of the berberine injection while avoiding the use of other cosolvents that increase the risk of clinical application, especially to solve the problem of Solve the problem that berberine injection adopts existing technology products to appear small white spots, white lumps, and solution turbidity in the case of long storage time, which can ensure that the visible foreign matter inspection of the product meets the requirements of drug quality standards, and is convenient for clinical use and promotion .

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of a berberine injection pharmaceutical composition. Background technique [0002] Berberine is an alkaloid extracted from the traditional Chinese medicine Ligusticum chuanxiong. Its chemical structure is tetramethylpyrazine. It is a new type of calcium ion antagonist. And bronchial smooth muscle, improve microcirculation and other functions, clinically used for occlusive cerebrovascular diseases such as cerebral insufficiency, cerebral thrombosis, cerebral embolism and other ischemic vascular diseases such as coronary heart disease, vasculitis, etc. The injection of berberine has made great contributions to the treatment of modern difficult diseases by traditional Chinese medicine. [0003] Because berberine has very poor solubility in aqueous solution, it is made into berberine hydrochloride or berberine phosphate to increase its water solubil...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/12A61K31/4375A61P9/10A61P9/14A61P7/02
CPCA61K9/08A61K9/0019A61K31/4375A61K47/12
Inventor 付裕
Owner CHENGDU XIANXIANXIAN BIOTECH CO LTD
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