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Establishment method and application of fingerprint spectrum of medicinal material, Marsdenia tenacissima and preparations of Marsdenia tenacissima

A technique of fingerprinting and establishing methods, which is applied in the field of quality control of traditional Chinese medicinal materials and their preparations, can solve problems such as inability to fully reflect the overall characteristics of medicinal materials and injections, drug efficacy, and poor control of the quality of injections, etc., to achieve Easy operation, high precision, good separation effect

Active Publication Date: 2014-06-25
NANJING SANHOME PHARMACEUTICAL CO LTD
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  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

However, the content of steroidal saponins is used as the index of quality control for Tongguanteng medicinal material, while the content of total phenolic acid is used as the index for quality control of its injection, and the determination of a single component content cannot fully reflect the overall characteristics of the medicinal material and injection. The efficacy of the medicine can not well control the quality of Tongguanteng medicinal materials and their injections

Method used

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  • Establishment method and application of fingerprint spectrum of medicinal material, Marsdenia tenacissima and preparations of Marsdenia tenacissima
  • Establishment method and application of fingerprint spectrum of medicinal material, Marsdenia tenacissima and preparations of Marsdenia tenacissima
  • Establishment method and application of fingerprint spectrum of medicinal material, Marsdenia tenacissima and preparations of Marsdenia tenacissima

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Methodological verification of fingerprints of steroidal saponins in Tengguan Teng medicinal material:

[0064] Chromatographic conditions: Column: Agilent ZORBAX SB-C 18 (250×4.6mm, 5μm); mobile phase A is water, mobile phase B is acetonitrile, gradient elution: 0~23min: 75%A→65%A, 25%B→35%B; 23~48min: 65 %A→50%A, 35%B→50%B; 48~60min: 50%A→50%A, 50%B→50%B; 60~90min: 50%A→20%A, 50%B →80%B; 90~100min: 20%A→10%A, 80%B→90%B; 100~101min: 10%A→75%A, 90%B→25%B; 101~120min: 75% %A→75%A, 25%B→25%B; column temperature: 35°C, flow rate: 0.8ml / min, detector: Alltech2000ES evaporative light scattering detector; atomization gas flow rate: 2.9L / min; drift Tube temperature: 106.5°C. The injection volume is 20 μL.

[0065] precision test

[0066] Take the same test solution, inject 6 times continuously, calculate the relative retention time and relative peak area of ​​the characteristic peak, the RSD is less than 0.04% and 1.4% respectively, and the similarity is greater than 0.95...

Embodiment 2

[0079] Methodological verification of fingerprints of phenolic acids in Tongguanteng injection:

[0080] Chromatographic conditions: Column: Agilent ZORBAX SB-C 18 (250×4.6mm, 5μm); mobile phase A is 0.05% phosphoric acid aqueous solution, mobile phase B is 0.05% phosphoric acid acetonitrile solution, gradient elution: 0~20min: 98%A→96%A, 2%B→4% B; 20~70min: 96%A→93%A, 4%B→7%B; 70~110min: 93%A→90%A, 7%B→10%B; 110~115min: 90%A→ 85%A, 10%B→15%B; 115~116min: 85%A→98%A, 15%B→2%B; equilibration time 10 minutes; flow rate 1.0ml / min; detection wavelength 300nm; column temperature 25 ℃.

[0081] (batch number 200706301), 6 consecutive injections (S1-S6), 20 μl each time, after the integration of the obtained chromatogram, the similarity with the control fingerprint was calculated by the fingerprint software, all above 0.95, see Table 4 and Figure 7 .

[0082] Table 4 Similarity of phenolic acids fingerprints in Tongguanteng Injection

[0083]

S1

S2

S3

...

Embodiment 3

[0092] Methodological verification of fingerprints of steroidal saponins in Tongguanteng injection:

[0093] Chromatographic conditions: Column: Agilent ZORBAX SB-C 18 (250×4.6mm, 5μm); mobile phase A is water, mobile phase B is acetonitrile, gradient elution: 0~110.0min: 90%A→44%A, 10%B→56%B; 110.0~110.1min : 44%A→90%A, 56%B→10%B; 110.1~120.0min: 90%A→90%A, 10%B→10%B; flow rate 0.8ml / min; column temperature 35℃, detection Detector: evaporative light scattering detector; atomization gas flow rate: 2.9 L / min; drift tube temperature: 106.5°C, injection volume 20 μl.

[0094] precision test

[0095] Take Tongguanteng injection (batch number: 200810241), inject 6 times continuously, calculate the relative retention time and relative peak area according to the characteristic peaks, the RSDs are less than 1% and 3% respectively, and the obtained chromatograms are integrated and calculated and compared by fingerprint software The similarity of the fingerprints is above 0.95, see T...

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Abstract

The invention relates to a fingerprint spectrum establishment method of a medicinal material, Marsdenia tenacissima, and preparations thereof and application of fingerprint spectrum to quality control of Marsdenia tenacissima and the preparations of Marsdenia tenacissima, and also discloses fingerprint spectrums of phenolic acids and steroid saponins in the Marsdenia tenacissima and the preparations and a determination method and application of the fingerprint spectrums. The fingerprint spectrums of phenolic acids and steroid saponins are utilized to control the quality of the Marsdenia tenacissima and the preparations thereof, so that the authenticity, the production place and the quality of the Marsdenia tenacissima can be identified and controlled, the really controllable standard on the quality of the Marsdenia tenacissima and the preparations thereof can be established, and the stable quality of the Marsdenia tenacissima and the preparations thereof is guaranteed. The method is used for controlling quality of the Marsdenia tenacissima and the preparations thereof by determining the fingerprint spectrums of phenolic acids and steroid saponins in the Marsdenia tenacissima and the preparations thereof, is simple to operate and is stable and reliable.

Description

[0001] This application is a divisional application of the Chinese patent application 201110128793.1 with the filing date of May 18, 2011 and the title of the invention is "Method and application for establishing fingerprints of Tongguan rattan medicinal materials and preparations". technical field [0002] The present invention relates to a quality control method of traditional Chinese medicinal materials and preparations thereof, in particular to a method for establishing high-performance liquid chromatography (HPLC) fingerprints of Tongguanteng medicinal materials and preparations thereof, and standard fingerprints of Tongguanteng medicinal materials and preparations thereof obtained by the method . Background technique [0003] Tongguan vine is the dry cane of Marsdenia tenacissima (Roxb.) Wight et Arn of Asclep iadaceae (Asclep iadaceae), also known as black bone vine, flat vine, lower milk vine, yellow wood fragrance, and big bitter Teng et al., first recorded in "Sout...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 王勇李迩娜钱金叶钦松沈振涛张仓
Owner NANJING SANHOME PHARMACEUTICAL CO LTD
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