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Injectable medicine composition capable of improving stability of puerarin medicine injection preparation and preparation method of injectable medicine composition

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

Inactive Publication Date: 2015-12-02
CHENGDU AIBIKE BIOTECH
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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 puerarin drug injection preparations, comprising the following steps: (1) weighing 0.1 g to 100 g of the raw material drug based on puerarin, 9.0 g of sodium chloride, citron 1mg-2.0g sodium citrate and 1mg-2.0g sodium citrate; (2) citric acid and sodium citrate were prepared into 10%-20% solutions respectively for later use. (3) Add 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 citric acid or sodium citrate solution, add water for injection below 40°C to 1000ml; (5) filter the liquid medicine until it is clear, fill it, and sterilize it.

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

[0027] Puerarin Hydrochloride 0.8g

[0028] Sodium chloride 9.0g

[0029...

Embodiment 2

[0033] Alternatively, the above pharmaceutical composition for injection that improves the stability of the puerarin drug injection preparation is prepared according to the following steps:

[0034] (1) Weigh 0.1g-100g of raw material medicine calculated as puerarin, 1mg-2.0g of citric acid, 1mg-2.0g of sodium citrate; (2) Prepare 10% of citric acid and sodium citrate respectively ~20% solution, set aside. (3) Add 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 citric acid or sodium citrate solution, add water for injection below 40°C to 1000ml; (5) filter the liquid medicine until it is clear, fill it, and sterilize it.

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

[0036] Puerarin Hydrochloride 20g

[0037] Citric acid 1.0g

[0038] Sodium citrate 2.0g

[...

Embodiment 3

[0041] Comparative Test of Stability of Puerarin and Sodium Chloride Injection

[0042]The detection of visible foreign matter of the puerarin sodium chloride 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 puerarin solution is solved. Sodium chloride injection is prone to problems such as small white spots, white lumps, and cloudy solution during storage. Utilize the puerarin sodium chloride injection that the present invention makes according to the relevant requirements of the Chinese Pharmacopoeia 2005 edition two appendix Ⅺ XC drug preparation stability test guiding principle, respectively inspected 24 months at 25 ℃, 6 at 40 ℃. 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 show that the product quality is ...

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PUM

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Abstract

The invention discloses an injectable medicine composition capable of improving the stability of a puerarin medicine injection preparation and a preparation method of the injectable medicine composition. The injectable medicine composition is mainly prepared by dissolving a puerarin salt in water for injection to obtain a liquid medicine, and adding citric acid and / or sodium citrate as a pH regulator to regulate the pH value of the liquid medicine, wherein the dose of citric acid and / or sodium citrate is 0.1-200.0 mg / 100 ml. Through adoption of the injectable medicine composition, the pH value of the puerarin medicine injection preparation can be more stable; compared with those in the prior art, degraded substances in puerarin are greatly reduced; under the circumstance that other solubilizing agents increasing the clinical application risk are avoided, the clarity of the puerarin medicine injection preparation is improved; particularly, the problem that when the conventional puerarin injection product is stored for a relatively long time, small white dots and white blocks are generated to result in solution turbidity can be solved. Therefore, examination of visible foreign matters in the puerarin medicine injection preparation can be guaranteed to accord with the medicine quality standard regulation, and clinical medication and promotion are facilitated.

Description

technical field [0001] The invention belongs to the technical field of medicine, and specifically refers to a pharmaceutical composition for injection that improves the stability of puerarin drug injection preparations. Background technique [0002] Puerarin is an alkaloid extracted from the traditional Chinese medicine Pueraria lobata. Its chemical structure is tetramethylpyrazine. It is a new type of calcium ion antagonist. Vascular and bronchial smooth muscle, improving 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. Puerarin injections have made great contributions to the treatment of modern difficult diseases by traditional Chinese medicine. [0003] Since puerarin has very poor solubility in aqueous solution, it is made into puerarin hydrochloride or puerarin phosphate ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/352A61K47/12A61P9/10A61P25/00A61P7/02A61P9/14
Inventor 何金蓉周洁
Owner CHENGDU AIBIKE BIOTECH
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