Gutweed total flavone, its prepn. method, freeze-drying powder injection containing it and quality control method therefor

A technology of freeze-dried powder injection and bitter dish, which is applied in freeze-dried delivery, powder delivery, pharmaceutical formulation, etc., and can solve problems such as difficulty in controlling quality and unclear active ingredients.

Active Publication Date: 2006-11-29
TONGHUA HUAXIA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Currently there is Dimailing injection in the market, but it is difficult to control its quality due to unclear active ingredients

Method used

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  • Gutweed total flavone, its prepn. method, freeze-drying powder injection containing it and quality control method therefor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] The preparation of embodiment 1 Kudiezi total flavonoids

[0077]Take Kudiezi herbs, add water to decoct twice, add 12 times the amount of water for the first time, decoct for 1 hour, add 10 times the amount of water for the second time, decoct for 1 hour; combine the decoctions, concentrate until each 1ml is equivalent to the original Take 1g of medicine, let it cool, add ethanol under stirring, make the alcohol content reach 80%, let it stand for 12 hours, filter under reduced pressure, add 10% calcium oxide milk under stirring to the filtrate, adjust the pH value to 11.0, let stand for 0.5 hour, Centrifuge, add 10 times the amount of water to the sediment, stir for 10 minutes, centrifuge, add ethanol to the sediment to make the alcohol content reach 90%, add 50% sulfuric acid solution under stirring, adjust the pH value to 5.0, centrifuge, add 40% % sodium hydroxide solution, adjust the pH value to 6.5, filter, and recover ethanol from the filtrate under reduced pres...

Embodiment 2

[0078] Example 2 Preparation of Kudiezi Freeze-dried Powder for Injection

[0079] Take 20g of total flavonoids of Kudiezi and 60g of mannitol, add an appropriate amount of water for injection to dissolve, steam sterilize at 100°C for 30 minutes, add water for injection to make up to 2000ml, filter under reduced pressure, and aseptically dispense the filtrate into vials, place In the drying oven, freeze at -40°C for 2-3 hours. When the condenser reaches -45°C, turn on the vacuum pump, open the drying oven and the condenser butterfly valve, and the vacuum in the drying oven will reach about 11Pa within about 30 minutes. The temperature is raised by 2°C per hour, and the temperature is raised to -20°C, and sublimated for 12 hours in total, and then the temperature is raised by 8°C per hour, until the temperature of the product and the partition is nearly the same, stop the machine, freeze-dry, seal and cap, and make 1000 pieces.

[0080] The prepared Kudiezi freeze-dried powder ...

experiment example 1

[0083] Effects of Experimental Example 1 on Rat Coronary Ligation Acute Myocardial Infarction (AMI) Model

[0084] Test drug: Kudiezi for injection, specification: containing refined Kudiezi total flavonoids 20mg / bottle (equivalent to 10g crude drug / bottle), prepared and provided by Tonghua Huaxia Pharmaceutical Co., Ltd. according to the method in Example 2. During the test, sodium chloride injection was used to prepare the required concentration, and the dose was calculated based on the amount of crude drug contained.

[0085] Negative control drug: sodium chloride injection, produced by Changchuncheng Pharmaceutical Co., Ltd., batch number: 20020810.

[0086] Positive control drug: Kudiezi (Diemailing) injection, specification: containing 6mg / 10ml of total flavonoids (equivalent to 10g crude drug / 10ml), provided by Tonghua Huaxia Pharmaceutical Co., Ltd., batch number: 20021205. During the test, sodium chloride injection was used to prepare the required concentration, and ...

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Abstract

A general ixeris flavone containing luteolin-7-0-beta-D-phranoglucuronide (C21H18O12), a freeze-dried powder injection prepared from said general ixeris flavone, mannitol and the water for injection, and the preparing process and quality control method of said freeze-dried powder injection are disclosed.

Description

technical field [0001] The invention relates to Kudiezi total flavonoids and a preparation method thereof, and also relates to Kudiezi freeze-dried powder injection containing the Kudiezi total flavonoids, belonging to the field of pharmacy. The invention also relates to a preparation method and a quality control method of the freeze-dried powder injection. Background technique [0002] Kudiezi is a 1-2-year-old dried herb (Ixeris sonchifolia (Bge) Hance), which has the effects of clearing heat and detoxifying, reducing swelling and relieving pain. It mainly contains flavonoids, adenosine, organic acids, coumarins, amino acids, phytosterols, sugars class etc. Modern medical research shows that flavonoids in Kudiezi have the functions of expanding heart and cerebrovascular, increasing coronary flow, inhibiting platelet aggregation, and inhibiting thrombus formation in vivo. At present, there is a medicine Dimailing injection in the market, but because the active ingredient ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/28A61K31/7048A61K9/19A61P9/10A61P7/02
Inventor 华玉强
Owner TONGHUA HUAXIA PHARMA
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