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Marsdenia tenacissima medicinal material, method for establishing fingerprints of marsdenia tenacissima medicinal material preparation and application of method

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: 2014-05-14
NANJING SANHOME PHARMACEUTICAL CO LTD
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  • Abstract
  • Description
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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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  • Marsdenia tenacissima medicinal material, method for establishing fingerprints of marsdenia tenacissima medicinal material preparation and application of method
  • Marsdenia tenacissima medicinal material, method for establishing fingerprints of marsdenia tenacissima medicinal material preparation and application of method
  • Marsdenia tenacissima medicinal material, method for establishing fingerprints of marsdenia tenacissima medicinal material preparation and application of method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Methodological verification of fingerprints of steroidal saponins in Tengguan Teng medicinal material:

[0063] 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.

[0064] precision test

[0065] Take the same test solution, continuously inject 6 times, 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

[0077] Methodological verification of fingerprints of phenolic acids in Tongguanteng injection:

[0078] 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: 98A→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°C.

[0079] (batch number 200706301), 6 consecutive injections (S1~A6), 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 .

[0080] Table 4 Similarity of phenolic acids fingerprints in Tongguanteng Injection

[0081]

S1

S2

S3

S4 ...

Embodiment 3

[0089] Methodological verification of fingerprints of steroidal saponins in Tongguanteng injection:

[0090] 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: 98%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.

[0091] precision test

[0092] Take Tongguanteng Injection (batch number: 2000810241), and 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 then calculated and compared by fingerprint software The similarity of the fingerprints is above 0...

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Abstract

The invention relates to a marsdenia tenacissima medicinal material, a method for establishing fingerprints of a marsdenia tenacissima medicinal material preparation, application of the method to quality control of the marsdenia tenacissima medicinal material and the preparation of marsdenia tenacissima medicinal material, and discloses fingerprints of phenolic acids and steroid saponins in the medicinal material and the preparation of marsdenia tenacissima, and a measurement method and an application of the fingerprints. The quality of the medicinal material and the preparation of marsdenia tenacissima is controlled by using the fingerprints of the phenolic acids and the steroid saponins, so that the identity, the producing area and the quality of the marsdenia tenacissima are identified and controlled, thus the quality of the medicinal material and the preparation of the marsdenia tenacissima has an actually controllable standard; stable quality of the medicinal material and the preparation of the marsdenia tenacissima is ensured. The method for controlling the quality of the marsdenia tenacissima through measuring the fingerprints of the phenolic acids and the steroid saponins in the medicinal material and the preparation of marsdenia tenacissima is simple, stable and reliable to operate.

Description

technical field [0001] 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 [0002] Tongguan vine is the dry cane of Marsdenia temacissima (Roxb.) Wight et Arn, a plant of the family 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 "Southern Yunnan Materia Medica", included in the 1974 edition of "Yunnan Provincial Drug Standards", the 1977 edition of "Chinese Pharmacopoeia" and the 2010 edition of "Chinese Pharmacopoeia". [0003] Tongguan vine is bitter in taste, slightly cold in nature, enter...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/88
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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