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Quality control method for pharmaceutic preparation containing sanguis draconis extract

A technology for pharmaceutical preparations and extracts, which is applied in the field of quality control of pharmaceutical preparations, can solve the problems of insufficient accuracy of thin-layer identification and spectrophotometry, and few detection items.

Active Publication Date: 2010-07-21
JIANGSU KANION PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The applicant of the present invention applied for a patent on September 12, 2002 called a preparation method of total flavonoids preparation of dragon's blood and its quality control method. The patent application number is: 02129687.1. This patent provides dragon's blood The quality control method of the total flavonoid preparation includes carrying out thin-layer identification of ascarin B, determining the content of ascarin B and 7,4′-dihydroxyflavone by spectrophotometry, and using high-performance liquid chromatography for 7,4′-dihydroxyflavone. 4'-dihydroxyflavone is assayed. These methods can carry out quality control to Longxuetong pharmaceutical preparations, but the items detected are less, and the accuracy of thin-layer identification and spectrophotometry is not good enough. The present invention is based on the prior art. On the basis of this method, the content determination of total phenols is added, and the method of using relatively accurate high performance liquid chromatography to determine the content of dragon's blood B is added. Not only that, the present invention also provides a method for the dissolution rate of Longxuetong pharmaceutical preparations. In addition, the present invention also provides the standard fingerprint of Longxuetong medicinal preparation and the application method of the diagram, which can more effectively control the quality of Longxuetong medicinal preparation

Method used

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  • Quality control method for pharmaceutic preparation containing sanguis draconis extract

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0287] Embodiment 1: the content determination method of total phenol:

[0288] a. Preparation of the reference substance solution: take an appropriate amount of 7,4′-dihydroxyflavone, accurately weigh it, put it in a brown measuring bottle, add absolute ethanol to make a solution containing 28 μg per 1 ml, and obtain it;

[0289] b. Preparation of standard curve: Accurately measure reference substance solution 0, 1.0, 2.0, 3.0, 4.0, 5.0ml, put them in 25ml measuring bottles respectively, add absolute ethanol to 5ml, add 0.3% dodecylsulfonic acid Sodium solution 2ml, 0.6% potassium ferricyanide solution 1ml, 0.9% ferric chloride solution 1ml, shake well, put it in a dark place for 5min, add 0.1M hydrochloric acid to the mark, shake well, put it away from light Place it for 35 minutes, and take the first copy as a blank; according to the UV-visible spectrophotometry method of Appendix VB of the Chinese Pharmacopoeia in 2005, measure the absorbance at 760nm, take the absorbance ...

Embodiment 2

[0292] Embodiment 2: the content determination method of total phenols:

[0293] a. Preparation of the reference substance solution: take an appropriate amount of 7,4′-dihydroxyflavone, accurately weigh it, put it in a brown measuring bottle, add absolute ethanol to make a solution containing 32 μg per 1 ml, and obtain it;

[0294] b. Preparation of standard curve: Accurately measure reference substance solution 0, 1.0, 2.0, 3.0, 4.0, 5.0ml, put them in 25ml measuring bottles respectively, add absolute ethanol to 5ml, add 0.3% dodecylsulfonic acid Sodium solution 2ml, 0.6% potassium ferricyanide solution 1ml, 0.9% ferric chloride solution 1ml, shake well, put it in a dark place for 5min, add 0.1M hydrochloric acid to the mark, shake well, put it away from light place at 780nm according to the ultraviolet-visible spectrophotometry method of appendix VB of the Chinese Pharmacopoeia in 2005, measure the absorbance at 780nm, take the absorbance as the ordinate, and the concentrati...

Embodiment 3

[0297] Embodiment 3: the content determination method of total phenol:

[0298] a. Preparation of the reference substance solution: take an appropriate amount of 7,4′-dihydroxyflavone, accurately weigh it, put it in a brown measuring bottle, add absolute ethanol to make a solution containing 36 μg per 1 ml, and obtain it;

[0299] b. Preparation of standard curve: Accurately measure reference substance solution 0, 1.0, 2.0, 3.0, 4.0, 5.0ml, put them in 25ml measuring bottles respectively, add absolute ethanol to 5ml, add 0.3% dodecylsulfonic acid Sodium solution 2ml, 0.6% potassium ferricyanide solution 1ml, 0.9% ferric chloride solution 1ml, shake well, put it in a dark place for 5min, add 0.1M hydrochloric acid to the mark, shake well, put it away from light Place it for 35 minutes, and take the first copy as a blank; according to the ultraviolet-visible spectrophotometry method of appendix VB of the Chinese Pharmacopoeia in 2005, measure the absorbance at 800nm, take the ab...

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Abstract

The invention provides a quality control method for pharmaceutic preparation containing sanguis draconis extract, which can adopt any one or more of the four quality control methods: (1) adopting an ultraviolet-visible spectrophotometry to measure the content of 7,4'-dyhydroxyl flavone; (2) adopting a high performance liquid chromatography to measure the content of lourerin B; (3) adopting the high performance liquid chromatography to detect finger-print; and (4) adopting the high performance liquid chromatography to detect dissolution by combining with a dissolution measurement method. The quality control method provided by the invention has good accuracy, precision and stability, and can effectively control the quality of pharmaceutic preparation containing the sanguis draconis extract.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine analysis, and relates to a quality control method of a pharmaceutical preparation containing extracts of Chinese medicinal materials, in particular to a method for quality control of pharmaceutical preparations containing extracts of dragon's blood. technical background [0002] Dracaena is the resin obtained by extracting the fat-containing wood of Dranaena cochinchinensis (Lour.) S.C.Chen. Mainly produced in Guangxi and Yunnan. According to "Compendium of Materia Medica", it is warm in nature, flat, sweet, salty, non-toxic, enters the blood system, and returns to the three meridians of lung, spleen, and kidney. Muscle sores and other significant effects. Modern medical research has confirmed that dragon's blood can improve the body's microcirculation, adjust the body's metabolism, and improve the body's immune function. [0003] The prescription of the pharmaceutical preparation co...

Claims

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Application Information

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IPC IPC(8): A61K36/889G01N21/33G01N30/36A61P37/02
Inventor 萧伟屠鹏飞王振中刘涛徐玉玲毕宇安邹艳萍章晨峰吴云孙永城
Owner JIANGSU KANION PHARMA CO LTD
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