Polyoxyethylene-660-12-hydroxy stearate containing breviscapine injection preparation and preparation method thereof

A technology of polyethylene glycol lauryl hydroxystearate and breviscapine, applied in the field of breviscapine injection preparations and its preparation, can solve the problems of increased impurity content, small amount of precipitation, and prone to precipitation solution, etc., and achieve high solubilization Ability to improve safety and avoid adverse reactions

Inactive Publication Date: 2014-10-29
CHENGDU LIST PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, breviscapine injection is prone to problems such as precipitation and solution turbidity during high temperature sterilization and long-term storage.
Current breviscapine injections often use polysorbate 80 as a solubilizer, but polysorbate 80 is prone to rancidity during high-temperature sterilization and long-term storage, resulting in an increa

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1 (the amount of HS15 is 0.01g / 100ml)

[0026] Breviscapine 4g

[0027] Disodium edetate 1g

[0028] HS15 0.1g

[0029] Dissolve 1 g of disodium edetate in 700 ml of water for injection, add 4 g of breviscapine, and stir to suspend. Add an appropriate amount of sodium bicarbonate, stir until the pH is 7~7.5, add 0.1gHS15, stir well to dissolve the scutellarin, add water for injection to 1000ml, add activated carbon with a volume of 0.1% of the solution, stir and adsorb After 20 minutes, charcoal removal, fine filtration, filling and sealing after passing the inspection of semi-finished products, sterilization by circulating steam at 100°C for 15 minutes, light inspection, and packaging.

Embodiment 1

[0035] Embodiment 1 and comparative example 1 safety contrast

[0036] Basis for judging safety: compare the safety according to the difference and degree of immune response produced by different prescription products (Example 1 and Control Example 1) of the present invention and the difference and degree of hemolysis produced by different prescription products on animals.

[0037] Results: Both the immune response and the hemolytic reaction produced in Example 1 were lower than those in Control Example 1.

[0038] Conclusion: The safety of the breviscapine injection preparation of the present invention (using polyethylene glycol lauryl hydroxystearate as a solubilizer) is obviously better than that of the current commercially available breviscapine drug injection preparation (using polysorbate 80 as a solubilizer). Solubilizers). It can be expected that in the future clinical application, the occurrence of adverse reactions such as allergy and hemolysis caused by polysorbate...

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PUM

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Abstract

The invention provides a breviscapine injection preparation with higher security and a preparation method thereof, the breviscapine injection preparation is an injection drug mainly prepared by together dissolving a breviscapine extract and polyoxyethylene-660-12-hydroxy stearate (solutol-HS15) as a solubilizer into injection water, and the use amount of the used polyoxyethylene-660-12-hydroxy stearate (solutol-HS15) is 0.01g / 100ml. The literature research in the prior art confirms that the security of the polyoxyethylene-660-12-hydroxy stearate (solutol-HS15) used in the preparation is far better than that of polysorbate-80; moreover, safety experiment shows that the security of a breviscapine injection liquid using the polyoxyethylene-660-12-hydroxy stearate (solutol-HS15) as the solubilizer is obviously better than that of a breviscapine injection liquid using the polysorbate-80 as a solubilizer.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a breviscapine injection preparation containing polyethylene glycol lauryl hydroxystearate and a preparation method thereof. Background technique [0002] The standards of breviscapine injection are recorded in the drug standards issued by the Ministry of Health (WS3─B─3822─98, the twentieth volume of traditional Chinese medicine preparations), and it is a sterilized aqueous solution of breviscapine. Dissolve 0.26g of disodium edetate in 280ml of water for injection, add 1g of breviscapine, stir to suspend, add an appropriate amount of sodium bicarbonate, stir while adding until the pH is 7-7.5, and fully stir to make The scutellarin is basically dissolved, add water for injection to 400ml, add 0.1% activated carbon in the solution volume, stir and absorb for 20 minutes, remove carbon, fine filter, fill and seal the semi-finished product after passing the inspection, an...

Claims

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Application Information

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IPC IPC(8): A61K31/7048A61K9/08A61K47/34A61P9/10
Inventor 张浩金红娣张熠
Owner CHENGDU LIST PHARMA
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