Checking method of Chinese medicinal composition standard fingerprint, and use thereof

A technology of fingerprint spectrum and detection method, 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: 2013-03-20
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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  • Checking method of Chinese medicinal composition standard fingerprint, and use thereof
  • Checking method of Chinese medicinal composition standard fingerprint, and use thereof
  • Checking method of Chinese medicinal composition standard fingerprint, and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0107] Embodiment 1: Fingerprint Spectrum Determination

[0108] The preparation method of capsule is as follows:

[0109] Prescription: Chuanxiong 784g Gastrodia elata 196g

[0110] 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

[0111] (1) Detection of fingerprint spectrum 1:

[0112] With reference to high performance liquid...

Embodiment 2

[0145] Embodiment 2: Obtaining of Standard Fingerprint 1.

[0146] 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 11, with similarity software Based on the fingerprints of these seventeen batches of test products, the "common pattern" was obtained as a standard fingerprint. The results are shown in image 3 .

[0147] Table 11 similarity of seventeen batches of finished capsules of this composition (wavelength 276nm)

[0148] batch number Similarity (Standard) 030205 0.967 030407 0.972 030404 0.970 030507 0.978 040403 0.973 040903 0.980 041001 0.973 041203 0.972 050205 0.973 050207 0.981

Embodiment 3

[0149] Embodiment 3: Obtaining of Standard Fingerprint 2.

[0150] 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 221nm), result calculation similarity, the results are shown in Table 12, use similarity software Based on the fingerprints of these ten batches of test products, the "common pattern" was obtained as a standard fingerprint. The results are shown in Figure 4 .

[0151] Table 12 Similarity of Ten Batches of Capsule Finished Products of the Composition (Wavelength 221nm)

[0152] batch number Similarity (Standard) 060501 0.987 060502 0.994 060503 0.997 060701 0.998 060702 0.994 060703 0.997 060901 0.998 061001 0.994 061101 0.997 061102 0.998

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Abstract

The invention belongs to the field of Chinese medicine analysis and discloses a Chinese medicinal composition standard fingerprint, a determination method thereof and use thereof. The standard fingerprint comprises two high performance liquid chromatography fingerprints: fingerprint 1 represented by a figure 3 and a fingerprint 2 represented by a figure 4. The standard fingerprint can be used forcontrolling the quality of Chinese medicinal compositions prepared by using szechuan lovage rhizome and tall gastrodia tuber as raw medicinal materials, wherein the similarity between the fingerprintof a qualified Chinese medicinal composition and the standard fingerprint is no less than 0.80. The standard fingerprint can reflect the overall quality information on products, thereby realizing overall and effective control over product quality. The identification of a measured fingerprint can be carried out by using a traditional Chinese medicament chromatographic fingerprint similarity evaluation system provided by Chinese Pharmacopoeia Commission and is convenient and quick in operation; and the conclusion of preparation fingerprint evaluation performed by using the obtained result of thesimilarity is more objective and accurate.

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 Patents(China)
IPC IPC(8): G01N30/86
Inventor 肖伟戴翔翎凌娅王振中毕宇安秦建平章晨峰陈凤龙
Owner JIANGSU KANION PHARMA CO LTD
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