Low-dielectric-constant solvent for injection and application thereof

A low dielectric constant, injection technology, applied in the field of medicine, can solve the difficult problems of Xuesaitong injection stability, high adverse reaction reports, quality changes during random inspection, etc., to achieve relaxation of quality requirements and product transportation and storage , good industrial applicability, and the effect of reducing production control costs

Pending Publication Date: 2019-11-22
KPC PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The glycosidic bonds of saponins are easily hydrolyzed in aqueous solution. Therefore, it is difficult to significantly improve the stability of Xuesaitong injection by improving the quality of total saponins of notoginseng and adjusting the pH value of the aqueous solution of total saponins of notoginseng
[0006] This is one of the main reasons for the relatively high clinical adverse reaction reports of Xuesaitong Injection; it is also the quality of Xuesaitong Injection produced by various pharmaceutical manufacturers was in good condition during the release test, but the quality of the drug supervision department during the market sampling inspection was relatively large main reason for change

Method used

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  • Low-dielectric-constant solvent for injection and application thereof
  • Low-dielectric-constant solvent for injection and application thereof
  • Low-dielectric-constant solvent for injection and application thereof

Examples

Experimental program
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Effect test

preparation example Construction

[0059] The method for preparing Xuesaitong injection prepared with a low dielectric constant solvent for injection of the present invention includes the following steps:

[0060] method one:

[0061] 1) Concentration: Heat 40-60% of the propylene glycol in the formula to 50-60°C, add the sodium chloride in the formula, keep stirring until the dissolution is complete, and then add the panax notoginseng saponins in the formula , Stir continuously until the dissolution is complete, add activated carbon with a mass percentage of 10-15% of the total saponins of Panax notoginseng. After stirring, let it stand for 20-40 minutes to decarbonize and obtain a concentrated liquid a;

[0062] 2) Dilute preparation: add the remaining 40-60% of the propylene glycol in the formula a to the concentrated solution a, stir and add 2~4% activated carbon of the total saponins of notoginseng saponins. After stirring, let it stand for 20-40min to remove the carbon. , Fine filtration to obtain liquid medici...

Embodiment 1

[0077] After heating 1500 g of propylene glycol to 55° C., add 25 g of sodium chloride and stir continuously until the dissolution is complete. Add 170g of panax notoginseng saponins and keep stirring until the dissolution is complete. Add 24 g of activated carbon, stir and let it stand for 30 minutes to decarburize to obtain a concentrated medicine. Add 1500 g of propylene glycol to the concentrated medicine, stir and add 6 g of activated carbon, stir and let stand for 30 minutes, decarburize, and finely filter to obtain a liquid medicine. Fill the liquid medicine into the ampoule and seal it. Then sterilize at 100°C for 30 minutes, and perform lamp inspection. Finally, the product is packaged according to the specifications.

[0078] The product is fully inspected according to the 2015 edition of the Chinese Pharmacopoeia and the quality standard for Xuesaitong injection WS1-B-3590-2001(Z)-2011 and is qualified.

Embodiment 2

[0080] After heating 1500 g of mixed solvent (volume percentage: propylene glycol: polyethylene glycol 400: water for injection = 25%: 25%: 50%) to 55°C, add 25 g of sodium chloride and stir continuously until the dissolution is complete. Add 170g of panax notoginseng saponins and keep stirring until the dissolution is complete. Add 24 g of activated carbon, stir and let it stand for 30 minutes to decarburize to obtain a concentrated medicine. Add 1500 g of mixed solvent (volume percentage: propylene glycol: polyethylene glycol 400: water for injection = 25%: 25%: 50%) to the concentrated medicine, stir and add 6 g of activated carbon, stir and let stand for 30 minutes, decarburize, and filter , Get the liquid medicine. Fill the liquid medicine into the ampoule and seal it. Then sterilize at 100°C for 30 minutes, and perform lamp inspection. Finally, the product is packaged according to the specifications.

[0081] The product is fully inspected according to the 2015 edition o...

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Abstract

The invention discloses a low-dielectric-constant solvent for injection and application thereof. The low-dielectric-constant solvent for injection is propylene glycol or a propylene glycol mixed solvent. The application is the application of the low-dielectric-constant solvent for injection to the preparation of unstable active ingredient injection and the application of the low-dielectric-constant solvent for injection to the preparation of xuesaitong injection. According to the prepared xuesaitong injection, the stability of the xuesaitong injection can be significantly improved when panax notoginseng saponins of same weight are used. The stability of xuesaitong injection can improve the safety of medications of patients, and meanwhile, manufacturing enterprises are enabled to appropriately broaden the quality requirements of panax notoginseng saponins and the requirements for product transportation and storage, the production costs and control costs of the enterprises are reduced, the medication cost of the patients is reduced, and industrial applicability is good.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a low dielectric constant solvent for injection and its application. Background technique [0002] Panax notoginseng is the dry root and rhizome of Panax notoginseng (Burk.) F.H. Chen, which is divided into main root, branch root and stem base. Mainly produced in Guangxi, Yunnan and other places, it has the functions of dispelling blood stasis and stopping bleeding, reducing swelling and pain. Xuesaitong injection is an injection made from the total saponins of notoginseng extracted from Panax notoginseng. It has the effects of promoting blood circulation, removing blood stasis, and activating collaterals. Used for stroke hemiplegia, blood stasis blocking the collaterals, sequelae of cerebrovascular disease, chest pain, heartache, central retinal vein occlusion and blood stasis block. [0003] The use of injections determines the extremely high requirements for safety. Xu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/10A61K9/08A61K36/258A61K31/704A61P9/10A61K125/00
CPCA61K47/10A61K9/08A61K9/0019A61K36/258A61K31/704A61P9/10
Inventor 谢波谢科
Owner KPC PHARM INC
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