Method for judging consistency of traditional Chinese medicine batches
A consistent, traditional Chinese medicine technology, applied in instruments, measuring devices, scientific instruments, etc., can solve problems such as unrealistic quality control, and achieve accurate judgment and simple methods.
Active Publication Date: 2013-05-22
SHANDONG UNIV
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Problems solved by technology
However, at this stage, for a complex analysis system such as traditional Chinese medicine, it is not realistic to achieve quality control through qualitative and quantitative analysis of all the ingredients contained in it.
Method used
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Embodiment 1
[0024] The traditional Chinese medicine used in Example 1 is Xinkeshu Tablets, and the sample batches are 71 batches. Xinkeshu Tablets, as a commonly used Chinese patent medicine for the treatment of coronary heart disease and angina pectoris, are mainly composed of Danshen, Pueraria root, Panax notoginseng, hawthorn and woody fragrance. The method of the present invention has no limitation on the traditional Chinese medicine used.
[0025] 1.1 Preparation of the test solution
[0026]Firstly, take appropriate amount of different batches (71 batches in this example) of Xinkeshu tablet samples, remove the outer coating film, and grind them. Precisely weigh 100 mg of finely ground sample powder, add 5 mL of 70% ethanol (volume percentage), ultrasonically extract at room temperature for 20 min, and take 4 mL and centrifuge at 3000 r / min for 10 min. Then take the supernatant and filter it through a 0.45 μm filter membrane, inject samples, and measure the original HPLC fingerprin...
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The invention discloses a method for judging consistency of traditional Chinese medicine batches. The method comprises the following steps: establishing a reference map on the basis of finger-print similarity analysis, and calculating the mahalanobis distance between a high performance liquid chromatography (HPLC) finger-print in traditional Chinese medicine samples in various batches and the reference map; converting the mahalanobis distance into F check so as to judge whether obvious difference exists between the HPLC finger-print in traditional Chinese medicine samples in different batches and the reference map under the level at a certain probability; and determining whether obvious difference exists in the content of components corresponding to chromatographic peaks in the HPLC finger-print in traditional Chinese medicine samples in various batches by employing a t checking method if the batch samples with obvious difference are determined according to the mahalanobis distance. The method is based on the chromatographic fingerprint and is simple, feasible and practical, the consistency of various batch samples can be judged from the probability according to the difference of the finger-print in traditional Chinese medicine samples in different batches, and method basis is provided for judging the consistency of the batches of the traditional Chinese medicine.
Description
technical field [0001] The invention relates to a method for judging the batch consistency of traditional Chinese medicines. Background technique [0002] Traditional Chinese medicine has been used to prevent and treat diseases for thousands of years. Different from synthetic drugs, the curative effect of traditional Chinese medicine and its preparations is mainly due to the synergistic effect of various components. In recent decades, due to its low toxicity and high efficacy, the demand of traditional Chinese medicine has been increasing year by year all over the world, especially in Asia, Europe and North America. The increase in demand also means higher requirements for quality standards. Each batch of traditional Chinese medicine should meet the specification requirements of specific products, such as production date and shelf life, etc. However, even simple preparations made from just a few herbs may contain hundreds of unique, specific ingredients, making quality co...
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IPC IPC(8): G01N30/02
Inventor 聂磊臧恒昌曾英姿王培段晓菊姜红
Owner SHANDONG UNIV