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Blood-production preparation quality test method and construction method of standard fingerprint spectrum thereof

A standard fingerprint and quality detection method technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems that the production process and product quality cannot be effectively controlled, and the clinical efficacy cannot be better guaranteed, so as to ensure the whole process of quality control , The pretreatment method is simple, the process is stable and uniform

Active Publication Date: 2015-05-27
KANGSHOU PHARMACY CO LTD HUNAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, there is no more comprehensive quality control method to reflect the quality status of existing Chinese medicinal materials, intermediates and finished products, nor can it effectively control the production process and product quality, and cannot better guarantee its clinical efficacy

Method used

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  • Blood-production preparation quality test method and construction method of standard fingerprint spectrum thereof
  • Blood-production preparation quality test method and construction method of standard fingerprint spectrum thereof
  • Blood-production preparation quality test method and construction method of standard fingerprint spectrum thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Example 1 Establishment of fingerprint of Shengxuebao preparation. (Take Shengxuebao Granules as an example)

[0054] (1) Instruments and reagents

[0055] Agilent 1260 HPLC, including online vacuum degasser (G-1311C), binary pump (G-1311C), standard autosampler (G-1329B), intelligent column oven (G-1316A) , DAD detector (G-1314B), Agilent1260Infinity chromatographic workstation (Agilent Technologies Co., Ltd.); SB-5200D ultrasonic cleaner (Ningbo Xinzhi Biotechnology Co., Ltd.); FAZ004B analytical balance (Shanghai Youke); BT125D electronic balance (Sartorius Scientific Instruments (Beijing) Co., Ltd.).

[0056] (2) Selection of chromatographic conditions

[0057] ①Selection of mobile phase

[0058] Select acetonitrile-water, acetonitrile-0.1% phosphoric acid solution, acetonitrile-0.2% phosphoric acid solution, acetonitrile-0.1% formic acid solution, methanol-0.1% phosphoric acid solution, methanol-0.1% formic acid solution, methanol-water, etc. to carry out the t...

Embodiment 2

[0091] Embodiment 2 The establishment of the fingerprint of Shengxuebao preparation intermediate

[0092] (1) Instruments and reagents

[0093] Agilent 1260 HPLC, including online vacuum degasser (G-1311C), binary pump (G-1311C), standard autosampler (G-1329B), intelligent column oven (G-1316A) , DAD detector (G-1314B), Agilent1260Infinity chromatographic workstation (Agilent Technologies Co., Ltd.); SB-5200D ultrasonic cleaner (Ningbo Xinzhi Biotechnology Co., Ltd.); FAZ004B analytical balance (Shanghai Youke); BT125D electronic balance (Sartorius Scientific Instruments (Beijing) Co., Ltd.).

[0094] (2) Chromatographic conditions

[0095] The column is Agilent ZORBAX XDB-C 18 (5μm, 4.6×250mm) reverse phase chromatographic column; column temperature is 25°C; detection wavelength is 200nm; mobile phase A is acetonitrile, mobile phase B is 0.1% phosphoric acid solution, the total flow rate is 1.0ml / min; analysis time is 60 minutes ; Elution gradient (see Table 4):

[0096]...

Embodiment 3

[0117] Example 3 Establishment of fingerprints of Shengxuebao preparations (taking Shengxuebao capsules as an example).

[0118] (1) Instruments and reagents

[0119] Agilent 1260 HPLC, including online vacuum degasser (G-1311C), binary pump (G-1311C), standard autosampler (G-1329B), intelligent column oven (G-1316A) , DAD detector (G-1314B), Agilent1260Infinity chromatographic workstation (Agilent Technologies Co., Ltd.); SB-5200D ultrasonic cleaner (Ningbo Xinzhi Biotechnology Co., Ltd.); FAZ004B analytical balance (Shanghai Youke); BT125D electronic balance (Sartorius Scientific Instruments (Beijing) Co., Ltd.).

[0120] (2) Chromatographic conditions

[0121] The column is Thermo Syncronis-C 18 (5μm, 4.6×250mm) reverse-phase chromatographic column; column temperature is 30°C; detection wavelength is 210nm; mobile phase A is acetonitrile, mobile phase B is 0.1% phosphoric acid solution, the total flow rate is 0.8ml / min; analysis time is 60 minutes ; Elution gradient (se...

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Abstract

The invention discloses a blood-production preparation quality test method which comprises the following steps: (1) preparation of a comparison product solution; (2) preparation of a test sample solution; (3) chromatographic conditions: a chromatographic column is C18 reversion phase chromatographic column; gradient elution is adopted, and a flowing phase is a gradient elution solution composed of acetonitrile and 0.1-0.2 percent of a phosphoric acid solution; the detection wavelength is 200-230 nanometers; the column temperature is 25-40 DEG C; the flowing speed is 0.8ml / min-1.2ml / min; the analysis lasts for 60 min; and (4) testing: the fingerprint spectrum is obtained through efficient liquid phase chromatography. The testing method provided by the invention is simple to operate, characteristic components are completely retained, and the testing method is good in repeatability and stability, high in precision and strong in specificity.

Description

technical field [0001] The invention belongs to the technical field of drug quality control, in particular to a method for detecting the quality of Shengxuebao preparations and a method for constructing a standard fingerprint. Background technique [0002] The Shengxuebao preparation is composed of seven medicinal materials: Polygonum multiflorum, Ligustrum lucidum, Mulberry, Eclipta, Radix Paeoniae Alba, Radix Astragali, and Dogji. This prescription has the effect of nourishing the liver and kidney, benefiting qi and blood, and is used for leukopenia, fatigue, soreness of the waist and knees, dizziness and tinnitus, palpitations, shortness of breath, insomnia, dry throat, loss of appetite and less food caused by malignant tumor radiotherapy and chemotherapy. . [0003] Anemia belongs to the categories of "blood deficiency", "blood dryness", "blood syndrome", "constancy" and "deficiency" in traditional Chinese medicine. "Huangdi Neijing" records: "Essence and energy seized...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 谈发金郑桂林柳卓
Owner KANGSHOU PHARMACY CO LTD HUNAN
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