Chinese ephedra prescription particle, preparation method and quality control method thereof

A technology of formula granules and ephedra, applied in medical raw materials derived from ephedra, color/spectral characteristic measurement, bulk transportation, etc., can solve problems such as backward large-scale production technology, influence of drug efficacy, limited transfer rate of ephedrine, etc.

Active Publication Date: 2009-01-14
BEIJING KANGRENTANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current defects of this product are: (1) The large-scale production process is backward, mostly traditional water extraction, the transfer rate of ephedrine is quite limited, and the efficacy of the drug is seriously affected; (2) the quality standard is exclusive to the quality control of ephedra formula granules General, can not really realize the quality control of the product in a complete sense
The current quality standard of this product can only guarantee that the product contains ephedrine hydrochloride, but cannot guarantee that the product is produced with ephedra as raw material, and lacks other quality information of the product, so it is impossible to accurately determine the quality of ephedra formula granules Poor and overall

Method used

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  • Chinese ephedra prescription particle, preparation method and quality control method thereof
  • Chinese ephedra prescription particle, preparation method and quality control method thereof
  • Chinese ephedra prescription particle, preparation method and quality control method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Embodiment 1: the preparation method of ephedra formula granule

[0064] The quality of the raw material ephedra is identified by infrared fingerprints. The identification method of infrared fingerprints is: use a Fourier transform infrared spectrometer with a measuring range of 4000cm -1 -400cm -1 , DTGS detector, resolution 4cm -1 , the number of scans is 16 times, the interference of water and carbon dioxide is always deducted during the scanning process, the relative humidity of the environment is lower than 60%, and the potassium bromide direct compression method is used for detection: the obtained results are consistent with the standard infrared fingerprint of ephedra; the characteristics of the standard infrared fingerprint of ephedra For: the strongest peak: peak position 1623cm -1 , with 1547cm -1 The peak forms a peak cluster with it; the second strongest peak: the peak position is 1032cm -1 , with 1103cm -1 The peak forms a peak cluster with it; the str...

Embodiment 2

[0066] Embodiment 2: the preparation method of ephedra formula granule

[0067] The quality of the raw material ephedra is identified by infrared fingerprints. The identification method of infrared fingerprints is: use a Fourier transform infrared spectrometer with a measuring range of 4000cm -1 -400cm -1 , DTGS detector, resolution 4cm -1 , the number of scans is 16 times, the interference of water and carbon dioxide is always deducted during the scanning process, and the relative humidity of the environment is lower than 60%. The characteristics of the infrared fingerprint spectrum are: the strongest peak: the peak position is 1623cm -1 , with 1547cm-1 The peak forms a peak cluster with it; the second strongest peak: the peak position is 1032cm -1 , with 1103cm -1 The peak forms a peak cluster with it; the stronger peak: the peak position is 2922cm -1 , at 2851cm -1 There is a peak forming a peak cluster with it; in addition, according to the intensity of the peaks fro...

Embodiment 3

[0069] Embodiment 3: the quality control method of the ephedra formula granule prepared in embodiment 1

[0070] A. Quality control of ephedra spray-dried powder: ephedra spray-dried powder adopts Fourier transform infrared spectrometer with a measuring range of 4000cm -1 -400cm -1 , DTGS detector, resolution 4cm -1 , the number of scans was 16 times, the interference of water and carbon dioxide was deducted from time to time during the scanning process, the relative humidity of the environment was lower than 60%, and the potassium bromide direct tablet method was used for detection; the obtained results were consistent with the standard infrared fingerprint of ephedra spray-dried powder, ephedra spray-dried The standard infrared fingerprint of the powder ( figure 2 ) is characterized by:

[0071] The strongest peak: peak position 1616cm -1 , with 1727cm -1 、1515cm -1 The two peaks form a peak cluster; the second strongest peak: the peak position is 1076cm -1 ;Stronger...

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Abstract

The invention discloses a herba ephedra prescription particle and a preparation method and a quality control method thereof. The prescription particle adopts the herba ephedrae as raw materials. Spraying dried herba ephedra powder is made by extracting the herba ephedrae with acidified water, concentrating the herba ephedrae under low pressure and low temperature and spray-drying the herba ephedrae. The herba ephedra particle is made by the spraying dried herba ephedra powder directly or by mixing the praying dried herba ephedra powder with proper quantities of auxiliary materials. Each herba ephedra prescription particle is equivalent to 10 grams of crude drug and the content of the ephedrine hydrochloride in the particle is not less than 3.0 percent. The herba ephedra prescription particle of the invention is provided with an IR fingerprint spectra as indicated in figure3.

Description

technical field [0001] The invention relates to a traditional Chinese medicine formula granule and a preparation method and a quality control method thereof, in particular to an ephedra formula granule and a preparation method and a quality control method thereof. Background technique [0002] The traditional preparation method of traditional Chinese medicine granules is: take Chinese herbal medicine pieces, decoct them with water, concentrate the decoction to a thick paste under reduced pressure, add dextrin, lactose or maltodextrin, wet granulate, dry, and package. The wet granulation needs to add a large amount of auxiliary materials (usually 7-8 times the amount of the thick paste) to the thick paste for filling. However, the prepared preparation has a low drug concentration and a large dosage, so the curative effect is not obvious. Traditional Chinese medicine formula granules are processed under the guidance of the theory of traditional Chinese medicine, using standar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/17A61K9/16G01N21/35A61K135/00
Inventor 吴玢付静陈明
Owner BEIJING KANGRENTANG PHARMA
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