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Application of intestinal absorption test in identifying potential unsafe components in Chinese medicine injection

An injection and intestinal absorption technology, which is applied in the application field of intestinal absorption experiment in identifying potentially unsafe components in traditional Chinese medicine injections, can solve the problems of bacterial contamination, out-of-control, and confusing quality of drugs, and achieves simplified workload, drug safety promotion, The effect of promoting development

Inactive Publication Date: 2010-09-22
孙悦平
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Problems solved by technology

[0015] In addition, it should be noted that there are various reasons for clinical adverse reaction accidents of traditional Chinese medicine injections. In addition to the lax quality standards of the medicine itself and the lack of identification and identification of potentially unsafe ingredients that may be contained, the safety of traditional Chinese medicine injections Many problems in production process control conditions, sterilization methods, aseptic environment in key production links, airtightness of packaging materials, raw material control and production quality management can lead to bacterial contamination, confusion or quality control of pharmaceuticals
Drug substandard or quality risks caused by these problems are not within the scope of the present invention

Method used

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  • Application of intestinal absorption test in identifying potential unsafe components in Chinese medicine injection
  • Application of intestinal absorption test in identifying potential unsafe components in Chinese medicine injection
  • Application of intestinal absorption test in identifying potential unsafe components in Chinese medicine injection

Examples

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Embodiment 1

[0054]Example 1: Application of Intestinal Absorption Test in Detection of Potentially Unsafe Components in Traditional Chinese Medicine Injections

[0055] 1) Determining the HPLC fingerprint of the Chinese medicine injection stock solution to be tested.

[0056] 2) if figure 1 As shown, the isolated intestinal tube 1 of the experimental animal was placed in an appropriate culture solution 4, and Krebs-Ringer bicarbonate buffer solution (pH 7.4) was used in this experiment. Connect the catheter 2 to both ends of the isolated intestinal tube 1 and ligate the intestinal tube, and continuously supply oxygen to the culture medium through the oxygen tube 7 ( figure 1 The circle near the mouth of the oxygen tube indicates air bubbles), the culture medium container is placed in a constant temperature water bath 5, and the water bath is 37 degrees Celsius to maintain its constant temperature, so that the isolated intestinal tube is in an environment close to physiological conditions...

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Abstract

The invention discloses application of an intestinal absorption test in identifying potential unsafe components in a Chinese medicine injection. An intestinal absorption test method and a liquid chromatography HPLC (High Performance Liquid Chromatography) fingerprint, and a pharmacokinetic method is firstly applied to a drug-quality standard research. By applying the intestinal absorption test to the security evaluation of the Chinese medicine injection, the application of the intestinal absorption test is helpful to establish a scientific quality control standard which can ensure the safety of the Chinese medicine injection and solve the problems of quality stability and safety of Chinese medicine injection products.

Description

technical field [0001] The invention relates to the application of intestinal absorption experiment in identifying potential unsafe components in fingerprints of traditional Chinese medicine injections. Background technique [0002] In the 1990s, the modernization of traditional Chinese medicine became an important development direction of traditional Chinese medicine, and the research on new dosage forms of traditional Chinese medicine including injections also became a symbol of the modernization of traditional Chinese medicine. In the production of injections, the quality stability and safety of the products have been improved to a certain extent. [0003] In recent years, with the improvement of the clinical adverse reaction monitoring system, the reports of clinical adverse reactions caused by traditional Chinese medicine injections have increased year by year, and there have been many fatal drug accidents. According to the data of the State Food and Drug Administratio...

Claims

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Application Information

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IPC IPC(8): G01N33/15G01N30/02
Inventor 孙悦平
Owner 孙悦平
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