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Xuesaitong injection preparation with polyethylene glycol 12-hydroxyl stearic acid ester and preparation method thereof

A technology of polyethylene glycol dodecyl stearate and injection preparation, applied in the field of Xuesaitong injection preparation and preparation thereof, can solve the problems of easy rancidity, increased impurity content, difficult to dissolve, etc., and achieves high physiological tolerance The effect of stability, high solubilization ability, and low hemolysis

Inactive Publication Date: 2015-06-03
CHENGDU LIST PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Since the main component of Xuesaitong injection is Panax notoginseng saponins, which are not easy to dissolve in water, Xuesaitong injection is prone to problems such as precipitation and solution turbidity during high-temperature sterilization and long-term storage.
The current Xuesaitong injection often uses polysorbate 80 as a solubilizer, but polysorbate 80 is prone to rancidity during high temperature sterilization and long-term storage, resulting in an increase in impurity content; and polysorbate 80 itself has a strong Hemolytic and allergic, which will increase the incidence of adverse reactions of injections
Moreover, the products added with polysorbate 80 as a solubilizer still have problems such as a small amount of precipitation and solution turbidity during long-term storage, thereby increasing the risk of clinical use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1 (the dosage of HS15 is 0.01g / 100ml)

[0030] Panax notoginseng saponins 4g

[0031] Disodium edetate 1g

[0032] HS15 0.1g

[0033] Dissolve 1 g of disodium edetate in 700 ml of water for injection, add 4 g of Panax notoginseng saponins, and stir to suspend. Add an appropriate amount of sodium bicarbonate, and stir until the pH is 7 to 7.5, add 0.1g HS15, stir well to dissolve the total saponins of Panax notoginseng, add water for injection to 1000ml, add activated carbon with 0.1% volume of the solution, and stir Adsorb for 20 minutes, remove charcoal, fine filter, fill and seal the semi-finished product after passing the inspection, and then sterilize by circulating steam at 100°C for 15 minutes, light inspection, and pack.

Embodiment 1

[0039] Embodiment 1 and comparative example 1 safety contrast

[0040] Safety judgment basis: according to different prescription products of the present invention ( Embodiment 1 and comparative example 1 ) and the difference and degree of immune response produced by different prescription products and the difference and degree of hemolysis in animals to compare their safety.

[0041] Results: Both the immune response and the hemolytic reaction produced in Example 1 were lower than those in Control Example 1. Conclusion: The safety of the Xuesaitong injection preparation of the present invention (using polyethylene glycol lauryl hydroxystearate as a solubilizer) is obviously better than that of the current commercially available Xuesaitong 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 80 ca...

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PUM

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Abstract

The invention provides a Xuesaitong injection preparation with polyethylene glycol 12-hydroxyl stearic acid ester and a preparation method thereof. The Xuesaitong injection preparation is mainly prepared by co-dissolving notoginseng total saponins, disodium edentate and polyethylene glycol 12-hydroxyl stearic acid ester servicing as a solubilizer together in water for injection, wherein dosage of the polyethylene glycol 12-hydroxyl stearic acid ester is 0.01g / 100ml. The Xuesaitong injection preparation utilizes the polyethylene glycol 12-hydroxyl stearic acid ester with higher safety as the solubilizer to prepare the Xuesaitong injection preparation, so as to solve potential safety hazard to some degree and product quality problems of commercially available Xuesaitong injection preparations and effectively avoid various adverse reactions of polysorbate 80 in clinical medication to greatly improve safety of the Xuesaitong injection preparation in clinical medication.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a Xuesaitong injection preparation containing polyethylene glycol lauryl hydroxystearate and a preparation method thereof. Background technique [0002] The standard of Xuesaitong injection is recorded in the drug standard 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 Panax notoginseng saponins. Dissolve 0.26g of disodium edetate in 280ml of water for injection, add 1g of Panax notoginseng saponins, stir to suspend, add an appropriate amount of sodium bicarbonate, stir while adding until the pH is 7-7.5, and stir well Make the total saponins of Panax notoginseng basically dissolve, add water for injection to 400ml, add activated carbon with a volume of 0.1% of the solution, stir and absorb for 20 minutes, remove carbon, fine filter, fill and seal the semi-fi...

Claims

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Application Information

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IPC IPC(8): A61K36/258A61K9/08A61K47/34A61P9/10A61P9/06A61P3/06A61P9/00
Inventor 张浩金红娣梁慧容
Owner CHENGDU LIST PHARMA