Standard fingerprint spectrum of Chinese medicinal composition, and measurement method and application thereof

A standard fingerprint and determination method technology, applied in the field of traditional Chinese medicine analysis, can solve the problem that traditional Chinese medicine has no mandatory requirements, and achieve the effect of objective conclusion and convenient operation

Active Publication Date: 2011-04-27
JIANGSU KANION PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the State Drug Administration has required relevant fingerprints for traditional Chinese medicine injections, which has played a key role in improving the quality of traditional Chinese medicine injections, but there is no mandatory requirement for other dosage forms of traditional Chinese medicine

Method used

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  • Standard fingerprint spectrum of Chinese medicinal composition, and measurement method and application thereof
  • Standard fingerprint spectrum of Chinese medicinal composition, and measurement method and application thereof
  • Standard fingerprint spectrum of Chinese medicinal composition, and measurement method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0084] Embodiment 1: Fingerprint Spectrum Determination

[0085] The preparation method of capsule is as follows:

[0086] Prescription: Chuanxiong 784g Gastrodia elata 196g

[0087] Preparation method: the above two flavors are crushed, mixed, extracted twice with 90% ethanol under reflux, each time for 2 hours, the extracts are combined, filtered, and the filtrate is recovered from ethanol and concentrated into clear ointment I with a relative density of 1.27 to 1.28; The slag is decocted twice with water, each time for 1 hour, the decoction is combined, filtered, the filtrate is concentrated into clear paste II with a relative density of 1.27-1.28, the above clear paste I and clear paste II are combined, an appropriate amount of silicon dioxide is added, vacuum Dry, pulverize, sieve, pack into capsules, make 1000 capsules, and get ready. Specifications: 0.34g per capsule

[0088] Fingerprint detection:

[0089] Take the contents of this product, mix well, grind finely, ...

Embodiment 2

[0095] Embodiment 2: Obtaining of standard fingerprint spectrum.

[0096] 10 batches of this Chinese medicine composition capsule finished product, prepare need testing solution by the preparation method of need testing solution, measure according to embodiment 1 method (detection wavelength is 276nm), result calculation similarity, the results are shown in Table 6, with similarity software Based on the fingerprints of these 10 batches of test products, the "common pattern" was obtained as a standard fingerprint. The results are shown in image 3 .

[0097] Table 6 Similarity of Ten Batches of Capsule Finished Products of the Composition (Wavelength 276nm)

[0098] batch number

Embodiment 3

[0099] Embodiment 3: the determination of product quality control standard

[0100] The similarity evaluation system for chromatographic fingerprints of traditional Chinese medicines stipulated by the National Pharmacopoeia Commission was adopted, and the version was the 2004 edition.

[0101] The fingerprints and standard fingerprints of the 10 batches of finished products described in Example 2 were used to calculate the similarity, and the fingerprints and standard fingerprints of the traditional Chinese medicine composition were calculated by similarity software, and the similarity was not less than 0.80.

[0102] The main characteristics of the fingerprint of the product quality control standard:

[0103] Present 6 main chromatographic peaks in this collection of figures, wherein No. 3 peak is the identical chromatographic peak with the peak retention time of reference material ferulic acid, compared with No. 3 peak retention time (by 1), other 5 chromatographic peaks The ...

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Abstract

The invention belongs to the field of analysis of traditional Chinese medicines, and discloses a standard fingerprint spectrum of a Chinese medicinal composition, and a measurement method and application thereof. The standard fingerprint spectrum is a high performance liquid chromatography spectrum; six main chromatographic peaks are shown in the spectrum; the No. 3 peak is the chromatographic peak which has the same peak retention time as ferulic acid serving as a reference object; and compared with the No. 3 peak, the other five chromatographic peaks have the relative retention time of 0.23+ / -10 percent, 0.27+ / -10 percent, 1.20+ / -8 percent, 1.65+ / -10 percent and 1.80+ / -10 percent respectively. The standard fingerprint spectrum can be used for quality control over the Chinese medicinal composition comprising szechuan lovage rhizome and tall gastrodia tuber serving as raw medicinal materials; and the similarity of the fingerprint spectrum of a qualified Chinese medicinal composition to the standard fingerprint spectrum is not less than 0.80. The standard fingerprint spectrum can completely and effectively control the product quality; a similarity evaluation system is adopted; and the invention has the advantages of convenience and high speed in operation and objective and accurate result.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine analysis and relates to a standard fingerprint of a traditional Chinese medicine composition preparation. The invention also relates to a method for measuring the standard fingerprint and the application of the standard fingerprint in the quality control of the composition. Background technique [0002] The traditional Chinese medicine composition involved in the present invention is a traditional Chinese medicine preparation prepared by combining Chuanxiong and Gastrodia elata according to a certain ratio, and adopting a process of combining water extraction and alcohol extraction. Prolonged headache caused by blockage of collaterals or hyperactivity of liver yang, pain in a fixed location, or dizziness and hypochondriac pain, insomnia, irritability, dark tongue or ecchymosis; angioneurotic headache. In order to more comprehensively and effectively control the quality control level of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/8988A61P25/04G01N30/86G01N30/02
Inventor 萧伟毕宇安胡军华秦建平王振中章晨峰
Owner JIANGSU KANION PHARMA CO LTD
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