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'Mailuoning' injection preparation and its quality control method

A quality control method and technology of Mailuoning, applied in the field of Mailuoning injection preparation and its quality control, can solve the problems of flocculation and sedimentation, single selection index, difficult product quality, etc.

Inactive Publication Date: 2007-12-12
TIANJIN TASLY ZHIJIAO PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The existing preparation process of Mailuoning Injection adopts water extraction and alcohol precipitation method to extract four medicinal materials simultaneously, and then extracts the active ingredients with ethyl acetate (see "Technical Method of Mailuoning Injection", Publication No. CN1078148A), However, the prescription contains chlorogenic acid and other components that are unstable to light and air, and the color change of the injection solution and the content of active ingredients are prone to decrease during storage. At the same time, there are organic acids and alkaloids in the prescription. These components are prone to flocculation and precipitation under the state of water injection, which seriously affects the safety and effectiveness of the clinical application of Mailuoning Injection.
[0008] The existing quality control method of Mailuoning injection comprises the TLC identification of chlorogenic acid and the content determination of binartemisinide (see the ministry standard WS3-B-3462-98), the selection index of this quality control method is single, the content Determination adopts thin-layer scanning method, and precision, accuracy are all not high, so, be difficult to carry out comprehensive control to product quality, make the incidence of adverse reaction be the trend of increasing year by year thus (Chen Aiqun et al. 70 cases of Mailuoning Injection Literature analysis of adverse reactions. Journal of Adverse Drug Reactions. 2003, 2: 162-165)

Method used

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  • 'Mailuoning' injection preparation and its quality control method
  • 'Mailuoning' injection preparation and its quality control method
  • 'Mailuoning' injection preparation and its quality control method

Examples

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Embodiment 1

[0206] The preparation of embodiment one Mailuoning powder injection

[0207] Get 3000g Dendrobium, 6000g Scrophulariaceae, 6000g Achyranthes bidentata, 5000g honeysuckle and grind them into coarse powder, use 70% ethanol to extract by percolation at a speed of 300ml / min, collect 12 times the percolation solution of the crude drug, recover ethanol under low temperature and decompression, and depressurize Concentrate to an extract with a relative density of 1.20 at 50°C, centrifuge to remove insoluble impurities, add 8 times the amount of water, stir thoroughly, let stand overnight, filter, and concentrate the filtrate under reduced pressure to an extract with a relative density of 1.15 at 50°C, filter , remove the precipitate, adjust the pH value to 1-2, extract 8 times with equal volume of ethyl acetate, combine the extracts, recover the ethyl acetate, and vacuum-dry at 50°C to obtain 338g of the extract. Add 2000ml of water for injection to the extract, heat and boil for 8 m...

Embodiment 2

[0209] Preparation of Yimailuoning Powder Injection

[0210] Get 5000g Dendrobium, 5000g Scrophulariaceae, 5000g Achyranthes bidentata, and 5000g honeysuckle and grind them into coarse powder, use 70% ethanol to extract by percolation at a speed of 100ml / min, collect 12 times the percolation solution of the crude drug, recycle ethanol under low temperature and decompression, and depressurize Concentrate to an extract with a relative density of 1.20 at 50°C, centrifuge to remove insoluble impurities, add 6 times the amount of water, stir well, let stand overnight, filter, and concentrate the filtrate under reduced pressure to an extract with a relative density of 1.20 at 50°C, filter , remove the precipitate, adjust the pH value to 1-2, extract 6 times with equal volume of ethyl acetate, combine the extracts, recover the ethyl acetate, and dry under vacuum at 60°C to obtain 345g of the extract. Add 2000ml of water for injection to the extract, heat and boil for 10 minutes, let ...

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Abstract

The invention discloses a Mailuoning powder injection and method for controlling its quality, wherein the medicament is prepared from Dendrobium nobile, achyranthes and cyathula root, scrophularia root and honeysuckle flower through steps of proportioning, extracting effective constituents, charging medicinal excipient, carrying out hyperfiltration, adjusting pH, degerming and filtering, freeze drying to obtain freeze dried powder injections. The quality control method consists of discriminating four kinds of Chinese herbs and contents of Scoparone, cinnamic acid and chlorogenic acid.

Description

technical field [0001] The present invention relates to a Mailuoning injection preparation, in particular to a Mailuoning injection preparation and a quality control method thereof. Background technique [0002] Mailuoning injection is a traditional Chinese medicine compound injection developed on the basis of the famous medical prescription "Simiao Yong'an Decoction". inflammation, arteriosclerotic obliterans, cerebral thrombosis and sequelae, polyarteritis, acute arterial embolism of extremities, diabetic gangrene, venous thrombosis and thrombophlebitis, etc. Chinese patent CN1557398A discloses that it also has the effect of preventing and treating angina pectoris. The main components and pharmacological effects of the four APIs are: [0003] Honeysuckle is the dried flower buds or flowers with early blooming of Lonicera japonica Thunb., Lonicera hypoglauca Miq., Lonicera confusa DC. or Lonicera dasystyla Rehd. It mainly contains organic acids. The currently identified ...

Claims

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Application Information

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IPC IPC(8): A61K36/8984A61K9/14A61P9/10A61P9/14A61P7/02G01N30/90G01N30/02G01N33/15
Inventor 叶正良郑永锋宋兆辉白雨
Owner TIANJIN TASLY ZHIJIAO PHARMA
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