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Intermediate of fathead tree medicinal materials and quality control method of injection

A quality control method and injection technology, applied in the quality control of danmu, the quality control of danmu injection, and the quality control of danmu medicinal materials, which can solve the problems of safety and effectiveness of difficult varieties

Active Publication Date: 2007-05-09
海南制药厂有限公司 +1
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] Danmu injection is a marketed drug with national standards, but its quality standard is relatively simple, and there are only some thin-layer identification methods, which cannot truly reflect the active ingredients of this variety and the group characteristics of the components, and it is difficult to effectively guarantee the quality of this variety. safety effectiveness

Method used

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  • Intermediate of fathead tree medicinal materials and quality control method of injection
  • Intermediate of fathead tree medicinal materials and quality control method of injection
  • Intermediate of fathead tree medicinal materials and quality control method of injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Example 1. A quality control method for Danmu injection, the method contains the following assay methods,

[0051] a. Chromatographic conditions and system suitability test: use octadecylsilane bonded silica gel as filler; 30:70:0.1 acetonitrile-water-phosphoric acid as mobile phase; detection wavelength is 226nm; The calculation of anthocyanin lactam should not be less than 5000;

[0052] b. Preparation of the reference substance solution: take an appropriate amount of vinblastam, accurately weigh it, add methanol to dissolve, and prepare solutions containing 100 μg / ml and 20 μg / ml of the reference substance;

[0053] c. Preparation of the test solution: accurately measure 1.0ml of the injection, put it in a 10ml measuring bottle, and distill it to volume;

[0054] d. Determination method: Precisely draw 10 μl each of the two concentrations of the reference substance solution and the test solution of the injection solution, respectively inject into the liquid chromat...

Embodiment 2

[0055] Example 2. A quality control method for Danmu injection, which is detected in combination with high performance liquid chromatography and fingerprints, the steps are as follows,

[0056] (1) Establish the standard fingerprint of Danmu injection,

[0057] a. Chromatographic conditions and system suitability test: Agilent 1100 series HPLC chromatograph, including binary high pressure pump, automatic sampling system, online degassing, column oven, DAD detector and other units; chromatographic column: Lichrospher C 18 , 5μm, 4.6×250mm; mobile phase: A is 0.1% phosphoric acid solution, B is 0.1% phosphoric acid acetonitrile solution, from 1% B to 35% B in 70min in a linear gradient, and then to 95% B in 5min, the flow rate : 1ml / min; Column temperature: 30°C; Detection wavelength: 226nm; Recording time: 72min;

[0058] Number of theoretical plates according to isovinblastam peak C 26 h 30 N 2 o 8 calculation, it should not be less than 5000;

[0059] b. Preparation of...

Embodiment 3

[0063] Example 3. The quality control method of the Danmu injection of embodiment 2, when establishing the standard fingerprint of the Danmu injection, at least 10 batches of the Danmu injection were taken, and the test solution was prepared according to the preparation method of the tested solution respectively. The above-mentioned acetonitrile is chromatographically pure, phosphoric acid is analytically pure, and water is ultrapure water. According to the detection data of at least 10 batches of Danmu injection obtained from the detection, the HPLC standard spectrum of Danmu injection is established, and the peak retention time and peak area are mainly established. Then import the detection data into Excel, calculate the average value of the relative retention time of each corresponding peak and the average value of the relative peak area, and multiply them with the average retention time and average peak area of ​​the reference peak respectively, as the peak retention of the...

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Abstract

A quality control method for medicinal fatheadtree wood, its intermediate and its injection features that the information about their chemical components are expressed by graphical method, so comparing them with each other and analyzing them easily and correctly.

Description

technical field [0001] The present invention relates to a quality control method of Chinese herbal medicine extract preparations, in particular to a quality control method of danmu injection; the invention also relates to a quality control method of danmu medicinal material; the present invention also relates to a danmu intermediate quality control methods. Background technique [0002] Danmu injection is a marketed drug with national standards, but its quality standard is relatively simple, and there are only some thin-layer identification methods, which cannot truly reflect the active ingredients of this variety and the group characteristics of the components, and it is difficult to effectively guarantee the quality of this variety. Safety and effectiveness. Contents of the invention [0003] The technical problem to be solved by the present invention is to provide a method for quality control of the gallwo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/74G01N30/02G01N33/15
Inventor 窦智丁岗雷彩霞李明慧刘文林沈鸣
Owner 海南制药厂有限公司
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