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A preparation method of hydroxysafflower yellow a freeze-dried powder injection and its product

A technology of freeze-dried powder injection and hydroxyl safflower, which is applied in the field of medicine and can solve problems such as poor stability and affecting drug stability

Active Publication Date: 2017-10-17
HARBIN MEDICAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Since hydroxysafflower yellow A is a chalcone derivative, its stability is poor, and high temperature sterilization will affect the stability of the drug

Method used

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  • A preparation method of hydroxysafflower yellow a freeze-dried powder injection and its product
  • A preparation method of hydroxysafflower yellow a freeze-dried powder injection and its product
  • A preparation method of hydroxysafflower yellow a freeze-dried powder injection and its product

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1, the preparation of hydroxysafflower yellow A freeze-dried powder injection

[0028] 1. Preparation of Hydroxysafflower Yellow A

[0029] 1.1 Grind dried safflower with a Chinese herbal medicine grinder, weigh 700g of dried safflower powder, add 7000ml of water to soak for 24h, then heat in a water bath at 50°C for 1h, ultrasonic at 50°C for 10 minutes, filter with 4 layers of gauze, and filter the total filtrate with suction. Obtain filtrate 1 and filter residue for use. The filter residue was heated again in a water bath at 50°C for 1 hour, ultrasonicated at 50°C for 10 minutes, filtered with 4 layers of gauze and suction filtered to obtain filtrate 2. Combine filtrate 1 and filtrate 2, filter, concentrate the filtrate to a relative density of 1.16-1.26, add ethanol to make the alcohol content reach 70% (v / v), refrigerate, let stand for 48 hours, filter, and recover ethanol from the filtrate, And concentrate to a relative density of 1.10-1.14, add ethan...

Embodiment 2

[0040] Example 2, Preparation of Hydroxysafflower Yellow A Freeze-dried Powder Injection

[0041] 1. Preparation of Hydroxysafflower Yellow A

[0042] 1.1 Grind dried safflower with a traditional Chinese medicinal material grinder, weigh 700g of dried safflower powder, add 7000ml of water to soak for 24h, heat in a water bath at 60°C for 1.5h, ultrasonic at 50°C for 5 minutes, filter with 4 layers of gauze, and filter the total filtrate with suction , to obtain filtrate 1 and filter residue for use. The filter residue was heated again in a water bath at 60°C for 1.5h, ultrasonicated at 50°C for 5 minutes, filtered through 4 layers of gauze and suction filtered to obtain filtrate 2. Combine filtrate 1 and filtrate 2, filter, concentrate the filtrate to a relative density of 1.16-1.26, add ethanol to make the alcohol content reach 70% (v / v), refrigerate, let stand for 72 hours, filter, and recover ethanol from the filtrate, and concentrated to a relative density of 1.10 to 1.1...

experiment example 1

[0052] Experimental Example 1: Investigation of the Process Flow and Stability Study of Safflower Injection

[0053] 1. Preparation process of 2010 Pharmacopoeia Safflower Injection

[0054] Take 500g of safflower, add water and decoct three times, the first time is 1 hour, the second time is 50 minutes, the third time is 30 minutes, the decoction is combined, filtered, the filtrate is concentrated to a relative density of 1.161-26, and ethanol is added to make the ethanol content reach 70%, refrigerate, stand still for 48 hours, filter, filtrate recover ethanol, and concentrate to a relative density of 1.10-1.14, add ethanol to make the alcohol content reach 80%, refrigerate, stand still for 48 hours, filter, filtrate Recover ethanol and concentrate to a relative density of 1.16-1.20, add 10 times the amount of water, refrigerate, let stand for 16-24 hours, filter, concentrate the filtrate to a relative density of 1.02-1.04, adjust the pH with 50% sodium hydroxide solution V...

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Abstract

The invention discloses a preparation method and a product of hydroxysafflor yellow A freeze-dried powder injection. The method comprises the following steps: adding hydroxysafflor yellow A, vitamin C and mannitol into a liquid dispensing cylinder, adding medical active carbon into the prepared liquid medicine, filtering, decarbonizing, sterilizing, fine filtering via a microfiltration membrane, packaging, adding a stopper, and finally freeze drying to obtain the hydroxysafflor yellow A freeze-dried powder injection. A pharmaceutical composition containing the hydroxysafflor yellow A is filtered and sterilized at a low temperature by using a filtration membrane and is put in a small bottle, the composition is frozen and is dewatered at vacuum to prepare the hydroxysafflor yellow A freeze-dried powder injection, and compared with the safflower injection prepared by using the traditional method, the stability and content of the hydroxysafflor yellow A in the prepared safflower injection prepared by adopting the method disclosed by the invention are improved.

Description

technical field [0001] The invention relates to a preparation method for isolating hydroxysafflower yellow A from traditional Chinese medicine safflower and preparing it into a freeze-dried powder injection and a product thereof, which belongs to the technical field of medicine. Background technique [0002] The traditional Chinese medicine safflower is a traditional Chinese medicine included in the Chinese Pharmacopoeia, which is widely used to treat cardiovascular and cerebrovascular diseases. Hydroxysafflower yellow A, the main component of safflower, has various pharmacological activities. Hydroxysafflower yellow A can antagonize platelet activating factor receptor binding; reduce myocardial infarct size; lower blood pressure, antithrombotic and inhibit platelet aggregation etc.; Hydroxy safflower yellow A can significantly reduce blood pressure and reduce heart rate, and hydroxy safflower yellow A can also inhibit apoptosis and protect cell cycle from damage to human um...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/351A61K47/22A61K47/10
Inventor 杨宝峰白玉华于学丽李磊吴立军
Owner HARBIN MEDICAL UNIVERSITY