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Panax notoginseng saponins freeze-dried powder injection and preparing method thereof

A technology for total saponins of Panax notoginseng and freeze-dried powder injection, applied in the field of medicine, can solve the problems of poor appearance and properties, influence product promotion and use, unsatisfactory formability, etc., and achieves improved appearance properties, strong aesthetics, and anti-vibration. strong effect

Active Publication Date: 2013-06-19
KPC PHARM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The product of this invention can solve the solubility problem and cancel the use of special injection solvent, but the formability of the product has not reached the ideal state, such as the product sticking to the wall, the product has poor uniformity and fineness inside the product, and the vibration resistance is not strong enough.
[0004] At present, the freeze-dried powder injection products of Panax notoginseng total saponins on the market include: Xuesaitong for injection and Xueshuantong for injection. These two products have the disadvantages of poor appearance, poor aesthetics, slow dissolution and poor vibration resistance. By the time of use, most of them have become fine powder and adhered to the inner wall of the bottle, which makes people feel of poor quality and affects the popularization and use of the product

Method used

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  • Panax notoginseng saponins freeze-dried powder injection and preparing method thereof
  • Panax notoginseng saponins freeze-dried powder injection and preparing method thereof
  • Panax notoginseng saponins freeze-dried powder injection and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Raw material formula: (prepared 10,000 sticks, product specifications: each stick contains 0.1g of Panax notoginseng saponins)

[0052] Panax notoginseng saponins 1.0kg

[0053] Mannitol 0.1kg

[0054] Sodium chloride 0.1kg

[0055] Preparation:

[0056] Under the production conditions of freeze-dried powder injection conforming to the "Good Manufacturing Practice for Drugs" (hereinafter referred to as GMP), take 1.0kg of qualified Panax notoginseng saponins according to the prescription, add 6L of water for injection, stir to dissolve, and then add sodium chloride 0.1kg, after dissolving, add 0.1kg of mannitol, stir to dissolve completely, add water for injection to a total volume of 10L, add activated carbon for needles with a total volume of 1% (W / V) (0.1kg), and absorb for 30 minutes , first use filter paper and sand rod to filter to remove activated carbon, after the filtrate is filtered through a 0.45μm filter membrane, adjust the pH value to 6.5-7.0 with 0.1mo...

Embodiment 2

[0058] Raw material formula: (prepared 10,000 sticks, product specifications: each stick contains 0.1g of Panax notoginseng saponins)

[0059] Panax notoginseng saponins 1.0kg

[0060] Mannitol 0.15kg

[0061] Sodium chloride 0.15kg

[0062] The technical requirements and operation process of preparation are the same as in Example 1.

Embodiment 3

[0064] Raw material formula: (prepared 10,000 sticks, product specifications: each stick contains 0.1g of Panax notoginseng saponins)

[0065] Panax notoginseng saponins 2.0kg

[0066] Mannitol 0.2kg

[0067] Sodium chloride 0.2kg

[0068] Preparation:

[0069] Under the production conditions of freeze-dried powder injections in compliance with GMP, take 2.0 kg of qualified Panax notoginseng saponins according to the prescription, add 12 L of water for injection, stir to dissolve, then add 0.2 kg of sodium chloride, and add 0.2 kg of mannitol after dissolving, Stir to dissolve completely, add water for injection to a total volume of 20L. Add activated carbon for needles with a total liquid volume of 1% (W / V) (0.2kg), and absorb for 30 minutes. First, filter with filter paper and sand bar to remove activated carbon. / L NaOH to adjust the pH value to 6.5-7.0, and finely filter with a filter membrane below 0.2 μm under the condition of grade 100. The fine filtrate is sent to...

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Abstract

The invention relates to a freeze-dried powder injection prescription of panax notoginseng saponins and a preparation method thereof. The invention uses panax notoginseng saponins as raw material, sodium chloride and mannitol as accessories. The preparation method takes raw material and accessories according to prescription to be added with water and dissolved, the mixture is absorbed by activated carbon to remove pyrogen and impurities, filtered, bottled, freeze-dried, etc., thus preparing the freeze-dried powder injection. The freeze-dried powder injection of panax notoginseng saponins obtained by the invention has good formability, high safety and stable and controllable quality. Compared with the existing freeze-dried powder injection of panax notoginseng saponins, the invention is characterized by good formability with beautiful appearance, good vibration resistance to resist the impact force generated by transportation, and good solubility due to fast dissolution without demanding special cosolvent, etc.

Description

technical field [0001] The present invention relates to the technical field of medicines, in particular to a drug that has the functions of promoting blood circulation and removing blood stasis, dredging meridians and activating collaterals, can improve and treat diseases of the blood circulation system, and is especially suitable for first aid and rehabilitation of cerebral ischemia and cardiovascular ischemic diseases. Panax notoginseng total saponins freeze-dried powder injection and preparation method thereof. Background technique [0002] Panax notoginseng (also known as Panax notoginseng, Tianqi, southern ginseng) is a plant of the genus Panax of Araliaceae. Its roots, leaves, flowers, etc. have medicinal value, mainly containing notoginseng saponins (content 2% to 14%) and other substances. Research data prove that the total saponins of Panax notoginseng are the main active ingredients of Panax notoginseng in promoting blood circulation and removing blood stasis, whi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/10A61K47/02A61K31/704A61K9/19A61P9/10
Inventor 张国丽黄照昌张嗣昆杨兆祥普俊学徐树光
Owner KPC PHARM INC
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