Rapid center control testing method of Xingnaojing injection

A technique for Xingnaojing injection and a detection method, which is applied in the field of near-infrared detection, can solve problems such as no relevant reports, achieve stable product quality, and improve quality control levels

Active Publication Date: 2015-01-21
WUXI JIYU SHANHE PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In the field of traditional Chinese medicine quality control and production application, the application of near-infrared spectroscopy technology to the detection of key indicators in the process of raw medicinal materials, finished products, distillation, concentration, alcohol precipitation, and chromatography has related patent documents, such as patent (patent application number: 200510130631.6 , 200810050095.2, 201010125515.6, 200910228468.5, 201010577454.7), etc. However, there are still no relevant reports on the use of near-infrared spectroscopy in the determination of key indicators in the distillation process of Xingnaojing injection

Method used

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  • Rapid center control testing method of Xingnaojing injection
  • Rapid center control testing method of Xingnaojing injection
  • Rapid center control testing method of Xingnaojing injection

Examples

Experimental program
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Effect test

Embodiment 1

[0059] (1) Distillate sample collection

[0060] Collection of distillate samples during the primary distillation of different batches of medicinal materials

[0061] One distillation process: turmeric and gardenia medicinal materials, add 25 times the amount of distilled water for distillation. After reaching the distillation temperature (keep warm, about one hour after the start of temperature rise), start to collect distillate samples, and the time interval of sample collection is 1 hour. The samples taken were used for the determination of curdione, curcumol, gemaconone and the total peak area of ​​the liquid phase respectively. The distillation extraction experiment of 6 batches of turmeric and gardenia medicinal materials was repeated, and samples were taken in the same way for each batch of experiments, and a total of 120 primary distillate samples were obtained.

[0062] (2) Determination of key indicators

[0063] Sample pretreatment method: Take 10ml of the distil...

Embodiment 2

[0078] According to the method of Example 1, the difference lies in the establishment of a rapid analysis model for each key index in the secondary distillation process.

[0079] (1) Collect distillate samples from different batches of medicinal materials during secondary distillation

[0080] Secondary distillation process: Take the primary distillate and add musk and appropriate amount of distilled water for distillation. After reaching the distillation temperature (keep warm, about one hour after the start of temperature rise), start to collect distillate samples, and the time interval of sample collection is 1 hour. The samples taken were used for the determination of curdione, curcumol, gemacone, muscone and the total peak area of ​​the liquid phase respectively. Six batches of secondary distillation experiments were repeated, and samples were taken in the same way for each batch of experiments. A total of 120 secondary distillation samples were obtained for establishing...

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Abstract

The invention relates to a rapid center control testing method of Xingnaojing injection. The rapid center control testing method comprises the following steps of: (1) acquiring samples of primary distillate and secondary distillate in the preparation process of the Xingnaojing injection of different batches; (2) testing the areas of the curcuma zedoary diketone, the curcumenol and the Germacrone in the distillate samples and the total liquid phase peak areas by using a liquid chromatographic method, and testing the muscone peak areas in the distillate samples by using a gas chromatographic method; (3) acquiring near infrared spectrum data of the distillate samples; (4) constructing a model; and (5) testing the content of the curcuma zedoary diketone, the curcumenol, the Germacrone and the muscone in unknown distillate samples.

Description

technical field [0001] The invention belongs to the field of near-infrared detection, and in particular relates to a multi-index rapid determination method for the distillation process of Xingnaojing injection. Background technique [0002] Xingnaojing Injection is a compound Chinese medicine preparation, which is a water-soluble intravenous injection obtained through scientific distillation from the traditional Chinese medicine prescription "Angong Niuhuang Pill". After intravenous administration, it can directly act on the blood-brain barrier. Central Nervous System. The medicine is mainly composed of musk, borneol, turmeric and gardenia. Among them, musk is fragrant, good at walking and channeling, and can open all orifices. All the orifices have the function of clearing away heat and detoxification; Curcuma is bitter and cold in nature, can clear away heat and relieve fire, cool blood and detoxify, resolve phlegm and open depression, and can cooperate with two medicines...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N21/359G01N21/3577
Inventor 周福康金叶朱俊峰甘国峰刘薇薇叶祖光
Owner WUXI JIYU SHANHE PHARM CO LTD
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