Preparation method of injecting drug improving stability of puerarin drug injection preparation

A technology for injection preparation and puerarin, applied in the field of medicine, can solve the problems of inconvenience of clinical medication and promotion, high risk of clinical application of injection, easy rancidity, etc. Reduced effect of degrading substances

Inactive Publication Date: 2015-12-09
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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  • Preparation method of injecting drug improving stability of puerarin drug injection preparation
  • Preparation method of injecting drug improving stability of puerarin drug injection preparation
  • Preparation method of injecting drug improving stability of puerarin drug injection preparation

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 1 mg to 2.0 g of sodium citrate and 1 mg to 2.0 g of sodium citrate; (2) citric acid and sodium citrate were prepared into 10% to 20% solutions 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 citric acid or sodium citrate 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.

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

[0027]

[0028] Citric acid and sodium citrate were prepared in...

Embodiment 2

[0030] Alternatively, the above pharmaceutical composition for injection that improves the stability of the puerarin drug injection preparation is prepared according to the following steps:

[0031] (1) Weigh 0.1g-100g of the raw material medicine calculated as puerarin, 1mg-2.0g of citric acid, and 1mg-2.0g of sodium citrate; (2) prepare 10% of citric acid and sodium citrate respectively ~20% 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 citric acid or sodium citrate 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.

[0032] The specific components and contents thereof of the present embodiment are as follows:

[0033] Puerarin Hydrochloride 20g

[0034] Citric acid 1.0g

[0035] Sodium citrate...

Embodiment 3

[0038] Comparative Test of Stability of Puerarin and Sodium Chloride Injection

[0039] 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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Abstract

The invention discloses a preparation method of injecting drug improving the stability of a puerarin drug injection preparation. An injecting drug composition is mainly prepared by dissolving puerarin salt in injecting water, adding citric acid and / or sodium citrate as a pH adjusting agent to adjust the pH value of the medicine liquid, and the dosage of the citric acid and / or sodium citrate is 0.1 to 200 mg / 100ml. By adopting the preparation method, the pH value of the injecting liquid is more stable, puerarin degraded substances are greatly reduced compared with the prior art, under the situation of not utilizing other co-solvent increasing the clinical application risk, the clarity of the puerarin injecting liquid is improved, the problems that the puerarin injecting liquid adopting a product of the prior art has small white points, white blocks and turbidity under the situation that the storage time is relatively long can be solved, the inspection on visible foreign matters of the product is enabled to meet the stipulation of the drug quality standard, and the clinical drug application and popularization are facilitated.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular refers to a preparation method of an injection medicine for improving the stability of a puerarin medicine injection preparation. 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 p...

Claims

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Application Information

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